These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM. CLOTRIMAZOLE and BET (2023)

Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.

Treatment of tinea corporis or tinea cruris:

Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week.
Do not use more than 45 grams per week. Do not use with occlusive dressings.
If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Do not use longer than 2 weeks.

Treatment of tinea pedis:

Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks.
Do not use more than 45 grams per week. Do not use with occlusive dressings.
If a patient shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Do not use longer than 4 weeks.

Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid contact with eyes. Wash hands after each application.

Cream, 1%/0.05%. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg of clotrimazole and 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a smooth white cream base.

None.

5.1 Effects on Endocrine System

Clotrimazole and betamethasone dipropionate cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Cushing's syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age.

Because of the potential for systemic corticosteroid effects, patients may need to be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a small trial, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult subjects. Three of the 8 normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal cosyntropin test. The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing [see Use in Specific Populations (8.4)].

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body mass ratios [see Use in Specific Populations (8.4)].

5.2 Diaper Dermatitis

The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended.

5.3 Ophthalmic Adverse Reactions

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including topical betamethasone products [see Adverse Reactions (6.2)].

Avoid contact of clotrimazole and betamethasone dipropionate cream with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency < 1% included rash, edema, and secondary infection.

6.2 Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following local adverse reactions have been reported with topical corticosteroids: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product).

Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.

Adverse reactions reported with the use of clotrimazole are: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.

8.1 Pregnancy

Risk Summary

There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy. Advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible.

There have been no reproduction studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. In an animal reproduction study, betamethasone dipropionate caused malformations (i.e., umbilical hernias, cephalocele, and cleft palate) in pregnant rabbits when given by the intramuscular route during organogenesis [see Data]. The available data do not allow the calculation of relevant comparisons between the systemic exposure of clotrimazole and/or betamethasone dipropionate observed in the animal studies to the systemic exposure that would be expected in humans after topical use of clotrimazole and betamethasone dipropionate cream.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

Clotrimazole

Studies in pregnant rats treated during organogenesis with intravaginal doses up to 100 mg/kg/day revealed no evidence of fetotoxicity due to clotrimazole exposure.

No increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) clotrimazole doses up to 100 mg/kg/day during gestation Days 6 to 15. However, clotrimazole dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights), and maternally toxic (reduced body weight gain) to rats. Clotrimazole dosed at 200 mg/kg/day was maternally lethal, and therefore, fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day had no adverse effects on dams or fetuses. However, in the combined fertility, embryofetal development, and postnatal development study conducted in rats, 50 mg/kg/day clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks [see Nonclinical Toxicology (13.1)].

Oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day did not cause malformations in pregnant mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally during organogenesis with 60, 120, or 180 mg/kg/day.

Betamethasone Dipropionate

Betamethasone dipropionate caused malformations when given to pregnant rabbits during organogenesis by the intramuscular route at doses of 0.05 mg/kg/day. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates.

8.2 Lactation

Risk Summary

There are no data regarding the excretion of betamethasone dipropionate or clotrimazole into breast milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding.

It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clotrimazole and betamethasone dipropionate cream and any potential adverse effects on the breastfed infant from clotrimazole and betamethasone dipropionate cream or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4)].

8.4 Pediatric Use

The use of clotrimazole and betamethasone dipropionate cream in patients under 17 years of age is not recommended.

Adverse events consistent with corticosteroid use have been observed in pediatric patients treated with clotrimazole and betamethasone dipropionate cream. In open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label trial, 8 of 17 (47.1%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are, therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids [see Warnings and Precautions (5.1)].

Avoid use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis.

8.5 Geriatric Use

Clinical studies of clotrimazole and betamethasone dipropionate cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, greater sensitivity of some older individuals cannot be ruled out. The use of clotrimazole and betamethasone dipropionate cream under occlusion, such as in diaper dermatitis, is not recommended.

Postmarket adverse event reporting for clotrimazole and betamethasone dipropionate cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin.

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use.

Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17CLN2, a molecular weight of 344.84, and the following structural formula:

These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM. CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1984 (1)

Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.

Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula:

These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM. CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1984 (2)

Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water.

Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative.

12.1 Mechanism of Action

Clotrimazole is an azole antifungal [see Clinical Pharmacology (12.4)].

Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris and tinea corporis is unknown.

12.2 Pharmacodynamics

Vasoconstrictor Assay:

Studies performed with clotrimazole and betamethasone dipropionate cream indicate that these topical combination antifungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high-potency topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3 Pharmacokinetics

Skin penetration and systemic absorption of clotrimazole and betamethasone dipropionate following topical application of clotrimazole and betamethasone dipropionate cream has not been studied.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see Dosage and Administration (2)].

Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

12.4 Microbiology

Mechanism of Action:

Clotrimazole, an azole antifungal agent, inhibits 14-α-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-α-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi.

Activity In Vitro and In Vivo:

Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in clinical infections, Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum [see Indications and Usage (1)].

Drug Resistance:

Strains of dermatophytes having a natural resistance to clotrimazole have not been reported. Resistance to azoles, including clotrimazole, has been reported in some Candida species.

No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of the combination of clotrimazole and betamethasone dipropionate or either component individually.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli) and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

In a combined study of the effects of clotrimazole on fertility, embryofetal development, and postnatal development, male and female rats were dosed orally (diet admixture) with dose levels of 5, 10, 25, or 50 mg/kg/day from 10 weeks prior to mating until 4 weeks postpartum. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.

Reproductive studies with betamethasone dipropionate conducted in rabbits at doses of 1.0 mg/kg/day by the intramuscular route and in mice up to 33 mg/kg/day by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species.

In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with clotrimazole and betamethasone dipropionate cream showed a better clinical response at the first return visit than subjects treated with clotrimazole cream. In tinea corporis and tinea cruris, the subject returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in subjects treated with clotrimazole and betamethasone dipropionate cream were as good as, or better than, in those subjects treated with clotrimazole cream. In these same clinical studies, patients treated with clotrimazole and betamethasone dipropionate cream showed better clinical responses and mycological cure rates when compared with subjects treated with betamethasone dipropionate cream.

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% is a smooth white cream and supplied in 15-gram (NDC 68788-8419-1 in boxes of one.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform the patient of the following:

Pregnancy

Advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)].

Lactation

Advise a woman to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)].

Important Administration Instructions

Inform the patient of the following:

Use clotrimazole and betamethasone dipropionate cream as directed by the physician. It is for external use only.
Avoid contact with the eyes, the mouth, or intravaginally.
Advise patients to report any visual symptoms to their healthcare providers.
Do not use clotrimazole and betamethasone dipropionate cream on the face or underarms.
Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream per week.
When using clotrimazole and betamethasone dipropionate cream in the groin area, patients should use the medication for 2 weeks only, and apply the cream sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks.
Do not use clotrimazole and betamethasone dipropionate cream for any disorder other than that for which it was prescribed.
Do not bandage, cover or wrap the treatment area unless directed by the physician. Avoid use of clotrimazole and betamethasone dipropionate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use.
This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis.

Mfd by:
Taro Pharmaceutical Industries Ltd.
Haifa Bay, Israel 2624761
Dist. by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Revised: October 2019
78428-1019-7

Relabeled by: Preferred Pharmaceuticals Inc.
89

Patient Information
Clotrimazole
(kloe trim' a zole) and Betamethasone Dipropionate
(bay" ta meth' a sone dye proe' pee oh nate) Cream USP, 1%/0.05%

Important information: Clotrimazole and betamethasone dipropionate cream is for use on skin only. Do not use clotrimazole and betamethasone dipropionate cream in your eyes, mouth, or vagina.

What is clotrimazole and betamethasone dipropionate cream?

Clotrimazole and betamethasone dipropionate cream is a prescription medication used on the skin (topical) to treat fungal infections of the feet, groin, and body in people 17 years of age and older. Clotrimazole and betamethasone dipropionate cream is used for fungal infections that are inflamed and have symptoms of redness or itching.
Clotrimazole and betamethasone dipropionate cream should not be used in children under 17 years of age.

Before using clotrimazole and betamethasone dipropionate cream, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. It is not known if clotrimazole and betamethasone dipropionate cream will harm your unborn baby. If you use clotrimazole and betamethasone dipropionate cream during pregnancy, use clotrimazole and betamethasone dipropionate cream on the smallest area of the skin and for the shortest time needed.
are breastfeeding or plan to breastfeed. It is not known if clotrimazole and betamethasone dipropionate cream passes into your breast milk. Breastfeeding women should use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.

How should I use clotrimazole and betamethasone dipropionate cream?

Use clotrimazole and betamethasone dipropionate cream exactly as your healthcare provider tells you to use it.
Use clotrimazole and betamethasone dipropionate cream for the prescribed treatment time, even if your symptoms get better.
Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream in 1 week.
Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. Wear loose-fitting clothing if you use clotrimazole and betamethasone dipropionate cream in the groin area.
Do not use clotrimazole and betamethasone dipropionate cream on your face or underarms (armpits).
For treatment of fungal infections of the groin and body:
Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 1 week.
Tell your healthcare provider if the treated skin area does not improve after 1 week of treatment.
Do not use clotrimazole and betamethasone dipropionate cream for longer than 2 weeks.
For treatment of fungal infections of the feet:
Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 2 weeks.
Tell your healthcare provider if the treated skin area does not improve after 2 weeks of treatment. Do not use clotrimazole and betamethasone dipropionate cream longer than 4 weeks.
Wash your hands after applying clotrimazole and betamethasone dipropionate cream.

What should I avoid while using clotrimazole and betamethasone dipropionate cream?
Clotrimazole and betamethasone dipropionate cream should not be used to treat diaper rash or redness. You should avoid applying clotrimazole and betamethasone dipropionate cream in the diaper area.

What are the possible side effects of clotrimazole and betamethasone dipropionate cream?
Clotrimazole and betamethasone dipropionate cream may cause serious side effects, including:

Clotrimazole and betamethasone dipropionate cream can pass through your skin. Too much clotrimazole and betamethasone dipropionate cream passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems.
Vision problems. Topical corticosteroids may increase your chance of developing cataracts and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with clotrimazole and betamethasone dipropionate cream.

The most common side effects of clotrimazole and betamethasone dipropionate cream include burning, tingling, rash, swelling, and infections.
These are not all the possible side effects of clotrimazole and betamethasone dipropionate cream.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store clotrimazole and betamethasone dipropionate cream?

Store clotrimazole and betamethasone dipropionate cream at room temperature between 68°F to 77°F (20°C to 25°C).
Keep clotrimazole and betamethasone dipropionate cream and all medicines out of the reach of children.

General information about the safe and effective use of clotrimazole and betamethasone dipropionate cream.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use clotrimazole and betamethasone dipropionate cream for a condition for which it was not prescribed. Do not give clotrimazole and betamethasone dipropionate cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clotrimazole and betamethasone dipropionate cream that is written for health professionals.

What are the ingredients in clotrimazole and betamethasone dipropionate cream?
Active ingredients: clotrimazole and betamethasone dipropionate
Inactive ingredients: ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative
For more information, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or www.taro.com.
Mfd by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: October 2019
78428-1019-7
89

Relabeled by: Preferred Pharmaceuticals Inc.

This Patient Information has been approved by the U.S. Food and Drug Administration.

NDC 68788-8419-1

15 g

Clotrimazole and Betamethasone
Dipropionate Cream USP, 1%/0.05%

ATTENTION PHARMACIST: Dispense with enclosed Patient Information Leaflet.

ATTENTION PATIENT: See Patient Information Leaflet before using this product.

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. NOT RECOMMENDED
FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.

Rx only

Keep this and all medications out of the reach of children.

TARO

Relabeled by: Preferred Pharmaceuticals Inc.

These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM. CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1984 (3)

Preferred Pharmaceuticals Inc.

FAQs

What is clotrimazole and betamethasone and dipropionate cream used for? ›

Clotrimazole and betamethasone topical combination is used to treat fungus infections. Clotrimazole works by killing the fungus or preventing its growth. Betamethasone, a corticosteroid (cortisone-like medicine or steroid), is used to help relieve redness, swelling, itching, and other discomfort of fungus infections.

Do you need a prescription for clotrimazole and betamethasone dipropionate cream? ›

Clotrimazole and betamethasone dipropionate cream is a prescription medication used on the skin (topical) to treat fungal infections of the feet, groin, and body in people 17 years of age and older.

How long does clotrimazole and betamethasone dipropionate cream take to work? ›

Betamethasone belongs to the group of medications called corticosteroids and it works by decreasing inflammation. Clotrimazole belongs to the group of medications called antifungals and it works by killing certain types of fungus. Once treatment is started, itching and redness are usually relieved within 3 to 5 days.

Can you use too much clotrimazole and betamethasone? ›

Using too much of betamethasone and clotrimazole or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time.

What are the side effects of clotrimazole and betamethasone dipropionate cream? ›

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  • Blistering, burning, itching, peeling, dryness, redness, or other signs of skin irritation not present before use of this medicine.
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings.
Feb 1, 2023

Is clotrimazole a strong steroid? ›

Clotrimazole is an azole antifungal that works by preventing the growth of fungus. Betamethasone is a strong corticosteroid that works by reducing the swelling, redness, and itching that occurs in the skin infection. This medication is not recommended for children younger than 17 years or for diaper rash.

Can you use betamethasone on your private parts? ›

This medicine is for use on the skin only. Do not get it in your eyes, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns.

What are the side effects of betamethasone dipropionate cream? ›

What side effects can this medication cause?
  • burning, itching, irritation, stinging, redness, or dryness of the skin.
  • acne.
  • unwanted hair growth.
  • skin color changes.
  • bruising or shiny skin.
  • tiny red bumps or rash around the mouth.
  • small white or red bumps on the skin.
Feb 15, 2018

What is clotrimazole cream used for private parts? ›

Vaginal clotrimazole is used to treat vaginal yeast infections in adults and children 12 years of age and older.. Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

What are the long term side effects of clotrimazole and betamethasone? ›

High doses or long-term use of betamethasone and clotrimazole topical can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Is clotrimazole and betamethasone dipropionate cream strong? ›

Clotrimazole is an azole antifungal that works by preventing the growth of fungus. Betamethasone is a strong corticosteroid that works by reducing the swelling, redness, and itching that occurs in the skin infection. This medication is not recommended for children younger than 17 years or for diaper rash.

Is clotrimazole and betamethasone a steroid? ›

What is this medication? CLOTRIMAZOLE; BETAMETHASONE (kloe TRIM a zole; bay ta METH a sone) is a corticosteroid and antifungal cream. It treats ringworm and infections like jock itch and athlete's foot. It also helps reduce swelling, redness, and itching caused by these infections.

What happens if you use clotrimazole for too long? ›

If you use too much clotrimazole cream, spray or solution or use it more often than you need to, it may make your skin irritated or red. If this happens, use less the next time.

When should you not use clotrimazole? ›

Do not use clotrimazole cream, spray or solution for more than 4 weeks, unless a doctor tells you to. Fungal infections can become resistant to clotrimazole and it can stop working properly. The most common side effect of clotrimazole is skin irritation in the area you've treated.

What can I use instead of clotrimazole and betamethasone? ›

  • Terbinafine.
  • Fluconazole.
  • Lotrisone.
  • Lamisil.
  • Miconazole topical.
  • Ketoconazole.

When do you stop using clotrimazole betamethasone cream? ›

How long can I use Lotrisone (clotrimazole / betamethasone)? If you're prescribed Lotrisone (clotrimazole / betamethasone) for ringworm or jock itch, don't use it for longer than 2 weeks.

Does clotrimazole make skin peel? ›

Clotrimazole may cause side effects. If you experience any of these symptoms, stop using clotrimazole and call your doctor: blistering, redness, swelling, itching, burning, stinging, peeling, hives, or skin cracks.

Can clotrimazole cause problems? ›

Clotrimazole cream, spray or solution can sometimes cause irritated or red skin, or pain or a burning or stinging feeling when you put it on. If you get these side effects and they do not go away, talk to your pharmacist or doctor.

What are the disadvantages of clotrimazole? ›

When using clotrimazole to treat vulvovaginal candidiasis, <10% of patients have a vulvar or vaginal burning sensation. Other side effects include rash, hives, blisters, burning, itching, peeling, redness, swelling, pain, or other signs of skin irritation.

How do I know if my rash is fungal or bacterial? ›

Skin infections caused by viruses usually result in red welts or blisters that can be itchy and/or painful. Meanwhile, fungal infections usually present with a red, scaly and itchy rash with occasional pustules.

Is clotrimazole hard on the liver? ›

The cause of the serum enzyme elevations during clotrimazole therapy is unknown, but many of the antifungal azoles have been implicated in causing liver injury. Because there is minimal systemic absorption, clotrimazole concentrations may not reach levels that could cause significant liver injury.

What happens when you stop using betamethasone? ›

When you stop using betamethasone skin treatments, skin conditions like eczema and psoriasis can flare up again. You can avoid this by gradually reducing the amount you put on, and how often you use it.

Is it safe to use clotrimazole and betamethasone cream on your face? ›

Do not use betamethasone and clotrimazole cream on the face or underarms. This medicine may raise the chance of cataracts or glaucoma. Talk with the doctor. If you are 65 or older, use betamethasone and clotrimazole cream with care.

How long does betamethasone ointment stay in your system? ›

Stopping the medication suddenly following long-term use may be dangerous. The cream commonly results in increased hair growth and skin irritation. Betamethasone belongs to the glucocorticoid class of medication.
...
Betamethasone.
Clinical data
Elimination half-life36-54 hours
ExcretionKidney (in urine)
Identifiers
32 more rows

Why is betamethasone banned in the US? ›

While legal as a therapeutic aid for horses, it is illegal when found in the blood on race day because it's considered a possible performance-enhancer.

What not to take with betamethasone? ›

What Other Drugs Interact with Betamethasone?
  • aminoglutethimide.
  • amphotericin B injection and potassium-depleting agents.
  • antibiotics, specifical macrolide.
  • anticholinesterases.
  • oral anticoagulants.
  • antidiabetics.
  • antitubercular drugs.
  • cholestyramine.

Is betamethasone a strong steroid? ›

Betamethasone is a corticosteroid that doctors use to treat skin conditions that cause inflammation and itchiness. People can use injectable or topical betamethasone. Betamethasone is available in different formulations, which range in potency from medium to super potent.

Which antifungal cream is best for private parts? ›

CLOTRIMAZOLE (kloe TRIM a zole) is an antifungal medicine. It is used to treat yeast infections of the vagina.

Do I rub in clotrimazole cream? ›

Apply enough clotrimazole to cover the affected and surrounding skin areas, and rub in gently. Keep this medicine away from the eyes.

Which cream is best for itching in private parts? ›

Clotrimazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

Which is stronger hydrocortisone or betamethasone? ›

Some types of betamethasone are up to 600 times as potent as hydrocortisone. Both medications are available in various forms, including: Ointments. Creams.

Which is better clotrimazole or hydrocortisone? ›

Clotrimazole topical has an average rating of 8.6 out of 10 from a total of 28 ratings on Drugs.com. 83% of reviewers reported a positive effect, while 8% reported a negative effect. Hydrocortisone topical has an average rating of 6.8 out of 10 from a total of 59 ratings on Drugs.com.

What's stronger than clotrimazole? ›

Butenafine (Mentax) could potentially work better or faster because it kills the fungus, compared to -azole antifungals like clotrimazole (Lotrimin AF) which mainly stop the fungus from growing.

What is the difference between cortisone and clotrimazole? ›

Clotrimazole is an antifungal which treats the root cause of fungal skin infections. Hydrocortisone is a mild topical steroid which reduces the swelling, redness and itching associated with inflammation of the skin.

Can clotrimazole increase blood pressure? ›

Clotrimazole may significantly increase the blood levels of tacrolimus. This may increase the risk of serious side effects such as kidney problems, hyperkalemia (high potassium levels in the blood), high blood pressure, heart failure, infections, and various types of malignancies including lymphoma and skin cancer.

How long does it take for betamethasone to work? ›

For most skin conditions, and in most people, some improvement is noted within three to four days of starting treatment. The majority of conditions should resolve within one week of betamethasone use.

How do I know if clotrimazole is working? ›

The symptoms of fungal infections, such as itching or soreness, should get better within a few days of treatment. Red and scaly skin may take longer to get better. You may need treatment for between 1 and 4 weeks. Keep using clotrimazole for 2 weeks even if your symptoms have gone.

How long does clotrimazole take to absorb into skin? ›

Always leave about 30 minutes between applying different products to the same area of skin, to give them time to be absorbed.

How long does it take for a fungal skin infection to clear up? ›

Key facts. Ketoconazole usually works within 2 to 3 weeks for most fungal infections, but it can take 6 weeks for athlete's foot to get better. It works by killing the yeasts (fungi) that cause the infections.

What happens if you use clotrimazole and you don t have a yeast infection? ›

If you don't really have a yeast infection, antifungals won't help you get better. They can actually prolong the real problem, because while you'll think you're treating the issue, the real cause will continue to develop.

Can you put clotrimazole on private area? ›

Clotrimazole is a cream that can be used inside the vagina or on the surrounding skin to treat itching, burning, or discomfort caused by a vaginal yeast infection.

What does a skin fungus rash look like? ›

A fungal rash is often red and itches or burns. You may have red, swollen bumps like pimples or scaly, flaky patches.

How long can you use clotrimazole and betamethasone dipropionate cream? ›

Adults and children 17 years of age and older—Apply to the affected skin area(s) 2 times a day, in the morning and evening, for 2 weeks. Children younger than 17 years of age—Use is not recommended.

Can clotrimazole and betamethasone irritate? ›

Common side effects of betamethasone and clotrimazole topical may include: numbness, tingling, or stinging; skin dryness or rash; swelling; or.

Where should you not apply betamethasone? ›

Avoid use in the genital and rectal areas and in skin creases and armpits unless directed by your doctor. If you are using betamethasone on a child's diaper area, do not use tight-fitting diapers or plastic pants. Such use may increase side effects.

What skin conditions does betamethasone treat? ›

Betamethasone skin treatments are used to treat itching, swollen and irritated skin. They can help with conditions such as eczema, contact dermatitis and psoriasis.

How do you apply clotrimazole cream in private parts? ›

Vaginal clotrimazole comes as a cream to be inserted into the vagina. It also may be applied to the skin around the outside of the vagina. The cream is inserted into the vagina once a day at bedtime for 3 or 7 days in a row, depending on the product instructions.

What ointment is good for private parts? ›

Antifungal Vaginal Cream
  • Gyne-Lotrimin (clotrimazole)
  • Gynazole (butoconazole)
  • Monistat (miconazole nitrate)
  • Vagistat (tioconazole)
Oct 18, 2022

What is the risk for betamethasone? ›

Infection risk warning: Steroids such as betamethasone suppress your body's immune system. This makes it harder for you to fight infections. Long-term use of betamethasone and using it in higher doses may increase your chances of getting an infection. It may also hide the symptoms of any infection you may have.

How quickly does betamethasone cream work? ›

Topical betamethasone – how long does it take to work? For most skin conditions, and in most people, some improvement is noted within three to four days of starting treatment. The majority of conditions should resolve within one week of betamethasone use.

How long do you leave clotrimazole on? ›

How long to use it for. How long you use clotrimazole for depends on the type of infection you have. It's best to use it for at least 2 weeks, even if all signs of the infection have gone, to stop it from coming back. You can use it for up to 4 weeks if needed.

What happens after applying clotrimazole? ›

Clotrimazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

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