Label: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- clotrimazole and betamethasone dipropionate cream

  • NDC Code(s): 0168-0258-15, 0168-0258-46
  • Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 03/15

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE Dipropionate Cream USP, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE Dipropionate Cream USP, 1%/0.05% (base).
    CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM USP, 1%/0.05% (base) for topical use
    Initial U.S. Approval: 1984

    INDICATIONS AND USAGE

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a 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. (1)

    DOSAGE AND ADMINISTRATION

    Tinea pedis: Apply a thin film to the affected skin areas twice a day for 2 weeks. ( 2)
    Tinea cruris and tinea corporis: Apply a thin film to the affected skin area twice a day for 1 week. ( 2)
    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and longer than 4 weeks in the treatment of tinea pedis. ( 2)
    Do not use with occlusive dressings unless directed by a physician. ( 2)
    Not for ophthalmic, oral or intravaginal use. ( 2)

    DOSAGE FORMS AND STRENGTHS

    Cream, 1%/0.05%. ( 3)
    Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg of clotrimazole, USP and 0.64 mg of betamethasone dipropionate, USP (equivalent to 0.5 mg of betamethasone) in white to off-white cream base. ( 3)

    CONTRAINDICATIONS

    None. ( 4)

    WARNINGS AND PRECAUTIONS

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment. Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop. ( 5.1, 8.4)
    Pediatric patients may be more susceptible to systemic toxicity. ( 5.1, 8.4)
    The use of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) in the treatment of diaper dermatitis is not recommended. ( 5.2)

    ADVERSE REACTIONS

    Most common adverse reactions reported for Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. (6.1)

    To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

    Revised: 3/2015

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  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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.

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  • 2 DOSAGE AND ADMINISTRATION

    Treatment of tinea corporis or tinea cruris:

    Apply a thin film of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base), 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 USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) the diagnosis should be reviewed.
    Do not use longer than 4 weeks.

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

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  • 3 DOSAGE FORMS AND STRENGTHS

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

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  • 4 CONTRAINDICATIONS

    None.

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  • 5 WARNINGS AND PRECAUTIONS

    5.1 Effects on Endocrine System

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) in the treatment of diaper dermatitis is not recommended.

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  • 6 ADVERSE REACTIONS

    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 USP, 1%/0.05% (base) 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).

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

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  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Teratogenic effects,

    Pregnancy Category C

    There are no adequate and well-controlled studies with Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) in pregnant women. Therefore, Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels.

    Studies in pregnant rats with intravaginal doses up to 100 mg/kg (15 times the maximum human dose) 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 (30 times the maximum human dose) was maternally lethal, and therefore, fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day (8 times the maximum human dose) had no adverse effects on dams or fetuses. However, in the combined fertility, teratogenicity, and postnatal development study described above, 50 mg/kg clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks.

    Oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day (2 to 15 times the maximum human dose) were not teratogenic in mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day (18 to 55 times the maximum human dose).

    Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates.

    Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

    8.3 Nursing Mothers

    Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) is administered to a nursing woman.

    8.4 Pediatric Use

    The use of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base). In open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) in the treatment of diaper dermatitis.

    8.5 Geriatric Use

    Clinical studies of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) under occlusion, such as in diaper dermatitis, is not recommended.

    Postmarket adverse event reporting for Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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.

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  • 11 DESCRIPTION

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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:

    Chemical Structure

    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:

    Chemical Structure

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

    Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetostearyl alcohol, ceteareth-30, propylene glycol, monobasic sodium phosphate monohydrate, and benzyl alcohol as a preservative.

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  • 12 CLINICAL PHARMACOLOGY

    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 USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) 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.

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  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis.

    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.

    Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the maximum human dose based on body surface areas, respectively.

    In a combined study of the effects of clotrimazole on fertility, teratogenicity, and postnatal development, male and female rats were dosed orally (diet admixture) with levels of 5, 10, 25, or 50 mg/kg/day (approximately 1 to 8 times the maximum dose in a 60-kg adult based on body surface area) 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.

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  • 14 CLINICAL STUDIES

    In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) showed better clinical responses and mycological cure rates when compared with subjects treated with betamethasone dipropionate cream.

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  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) is supplied as follows:
    NDC 0168-0258-15, 15 gram tubes
    NDC 0168-0258-46, 45 gram tubes

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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  • 17 PATIENT COUNSELING INFORMATION

    See FDA-Approved Patient Labeling (Patient Information)

    Inform the patient of the following:

    Use Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) as directed by the physician. It is for external use only.
    Avoid contact with the eyes, the mouth, or intravaginally.
    Do not use Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) on the face or underarms.
    Do not use more than 45 grams of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) per week.
    When using Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) 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.

    E. FOUGERA & CO.
    A division of
    Fougera
    PHARMACEUTICALS INC.
    Melville, New York 11747
    46148682A
    R03/15
    #52

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  • Patient Information

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)

    Important information: Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) is for use on skin only. Do not use Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) in your eyes, mouth, or vagina.

    What is Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)?

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) is used for fungal infections that are inflamed and have symptoms of redness or itching.
    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) should not be used in children under 17 years of age.

    Before using Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base), 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 USP, 1%/0.05% (base) will harm your unborn baby.
    are breastfeeding or plan to breastfeed. It is not known if Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) passes into your breast milk.

    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.

    What should I avoid while using Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)?

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) should not be used to treat diaper rash or redness. You should avoid applying Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) in the diaper area.

    How should I use Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)?

    Use Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) exactly as your healthcare provider tells you to use it.
    Use Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) for the prescribed treatment time, even if your symptoms get better.
    Do not use more than 45 grams of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) in the groin area.
    Do not use Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) for longer than 2 weeks.
    For treatment of fungal infections of the feet:
    Apply a thin layer of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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 USP, 1%/0.05% (base) longer than 4 weeks.
    Wash your hands after applying Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base).

    What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)?

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) may cause serious side effects, including:

    Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) can pass through your skin. Too much Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) 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.

    The most common side effects of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) include burning, tingling, rash, swelling, and infections.

    These are not all the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base).

    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 USP, 1%/0.05% (base)?

    Store Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) at room temperature between 68° to 77°F (20° to 25°C)
    Keep Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) and all medicines out of the reach of children.

    General information about the safe and effective use of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base).

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) that is written for health professionals. Do not use Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) for a condition for which it was not prescribed. Do not give Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) to other people, even if they have the same symptoms that you have. It may harm them.

    What are the ingredients in Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)?

    Active ingredients: clotrimazole and betamethasone dipropionate

    Inactive ingredients: purified water, mineral oil, white petrolatum, cetostearyl alcohol, ceteareth-30, propylene glycol, monobasic sodium phosphate monohydrate, and benzyl alcohol as a preservative.

    E. FOUGERA & CO.
    A division of
    Fougera
    PHARMACEUTICALS INC.
    Melville, New York 11747
    46148682A
    R03/15
    #52

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 15 g Tube

    NDC 0168-0258-15

    Fougera

    CLOTRIMAZOLE and
    BETAMETHASONE
    DIPROPIONATE CREAM
    USP, 1%/0.05% (base)

    Rx only

    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.

    NET WT 15 grams

    PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 15 g Carton

    NDC 0168-0258-15

    Rx only

    Fougera

    CLOTRIMAZOLE and
    BETAMETHASONE DIPROPIONATE
    CREAM USP, 1%/0.05% (base)

    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.

    NET WT 15 grams

    PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE 
    clotrimazole and betamethasone dipropionate cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0258
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    clotrimazole (UNII: G07GZ97H65) (clotrimazole - UNII:G07GZ97H65) clotrimazole 10 mg  in 1 g
    BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE 0.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARETH-30 (UNII: 1R9DCZ5FOX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0258-15 15 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:0168-0258-46 45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075502 06/05/2001
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
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