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Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream — NDC 63187-0095-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream — NDC 63187-095-15 (Billing 63187-0095-15)

by Proficient Rx LP · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream from Proficient Rx LP, marketed since Jan 2007 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 63187-0095-15
🏷️ FDA NDC (as labeled) 63187-095-15 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Pack sizes2 compare ↓
Also priced by: Part D plans $0.3646/unit — full pricing hub ↓
Main listing for product 63187-095 · Also comes in: 45 g 63187-095-45
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-095-15
Product NDC 63187-095
11-digit billing NDC 63187009515
NCPDP billing unit GM — per gram (weight)
RxCUI 308714
UNII G07GZ97H65, 826Y60901U
Application # ANDA076002
SPL Set ID 3d235926-6f17-4aa5-be82-7f1b4357e247
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-01-03
Route TOPICAL
Dosage form CREAM
Substance CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90159902053710
GPI class Clotrimazole-Betamethasone
GCN Seq No 036534
GCN 06919
HICL code 003197
Ingredient (HICL) Clotrimazole/Betamethasone Dip
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5M
Therapeutic class — specific (HIC3) Topical Antifungal/Anti-Inflammatory,Steroid Agent
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name CLOTRIMAZOLE-BETAMETHASONE CRM
FDB brand name Clotrimazole-Betamethasone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 036534
  • GCN: 06919
  • GPI-14 (Medi-Span): 90159902053710
  • HICL (First Databank): 003197
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 308714
Why two NDCs? The FDA registers this code as 63187-095-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0095-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CLOTRIMAZOLE-BETAMETHASONE CRM Ingredient Clotrimazole/Betamethasone Dip
📖 What it is MedlinePlus · NLM

Betamethasone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Betamethasone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3646 $5.47 / 15 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0095-15 You're viewing this Main listing 1 TUBE in 1 CARTON / 15 g in 1 TUBE 2018-11-01 — Active
63187-0095-45 63187-095-45 1 TUBE in 1 CARTON / 45 g in 1 TUBE 2018-11-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 00168-0258-15 E. 15 g $0.201 AB Availability likely —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 00472-0379-15 Actavis 1 tube $0.201 AB Availability likely —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 16714-0496-01 NORTHSTAR 1 tube $0.201 AB Availability likely —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 51672-4048-01 Sun 1 tube $0.201 AB Availability likely —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 68462-0298-17 Glenmark 15 g $0.226 — FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 50090-0741-00 A-S 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 50090-3121-00 A-S 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 50090-4876-00 A-S 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 50090-6474-00 A-S 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/gthis 63187-0095-15 Proficient 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 63629-8758-01 Bryant 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 68071-4134-04 NuCare 45 g — — FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 68788-8419-01 Preferred 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 70518-2352-00 REMEDYREPACK 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 71205-0524-15 Proficient 15 g — — FDA listed —
Clotrimazole And Betamethasone Dipropionate 10 mg/g; .5 mg/g 72189-0182-15 Direct 15 g — — FDA listed —
Clotrimazole/Betameth .5 mg/g; 10 mg/g 72189-0518-15 Direct_Rx 15 g — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 80425-0344-01 Advanced 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 85766-0196-15 Sportpharm 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 67296-2272-01 Redpharm 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Jan 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 1R9DCZ5FOX
    A synthetic ingredient made by combining fatty alcohols with ethylene oxide. It helps oils and water mix together in the formula and makes the product smoother and easier to apply.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderACTAVIS MID ATLANTIC LLC
FDA applicationANDA076002 (ANDA)
Labeler code63187
First marketedJan 2007
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 119 words ▾

INDICATIONS AND USAGE Clotrimazole and Betamethasone Dipropionate Cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum . Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections.

The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis ) has not been established. Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported

⏱️ Dosage and Administration 168 words ▾

DOSAGE AND ADMINISTRATION Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening. Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.

Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.

⛔ Contraindications 28 words ▾

CONTRAINDICATIONS Clotrimazole and betamethasone dipropionate cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

🤒 Adverse Reactions 180 words ▾

ADVERSE REACTIONS Adverse reactions reported for clotrimazole and betamethasone dipropionate cream in clinical trials were paresthesia in 1 . 9% of patients, and rash, edema, and secondary infection, each in less than 1% of patients. The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings.

These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), and sensitization (local reactions upon repeated application of product). In the pediatric population, reported adverse events for clotrimazole and betamethasone dipropionate cream include growth retardation, benign intracranial hypertension, Cushing’s syndrome (HPA axis suppression), and local cutaneous reactions, including skin atrophy.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria and general irritation of the skin.

🤰 Pregnancy ~2 min read ▾

Pregnancy Teratogenic Effects Pregnancy Category C: 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 6-15. 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 (2-15 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 (18-55 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. There are no adequate and well-controlled studies in pregnant women of the teratogenic effects of topically applied corticosteroids. Therefore, clotrimazole and betamethasone dipropionate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use Adverse events consistent with corticosteroid use have been observed in patients under 12 years of age treated with clotrimazole and betamethasone dipropionate cream. In open-label studies, 17 of 43 (39 . 5%) evaluable pediatric patients (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 study, 8 of 17 (47 . 1%) evaluable pediatric patients (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. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM IN THE TREATMENT OF PATIENTS UNDER 17 YEARS OF AGE OR PATIENTS WITH DIAPER DERMATITIS IS NOT RECOMMENDED.

Because of higher ratio of skin surface area to body mass, pediatric patients under the age of 12 years are at a higher risk with clotrimazole and betamethasone dipropionate cream. The studies described above suggest that pediatric patients under the age of 17 years may also have this risk. They are at increased risk of developing Cushing’s syndrome while on treatment and adrenal insufficiency after withdrawal of treatment.

Adverse effects, including striae and growth retardation, have been reported with inappropriate use of clotrimazole and betamethasone dipropionate cream in infants and children (see PRECAUTIONS and ADVERSE REACTIONS ). Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

🧓 Geriatric Use 92 words ▾

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. Post market 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.

THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM UNDER OCCLUSION, SUCH AS IN DIAPER DERMATITIS, IS NOT RECOMMENDED.

🆘 Overdosage 83 words ▾

OVERDOSAGE Amounts greater than 45 g/week of clotrimazole and betamethasone dipropionate cream should not be used. Acute overdosage with topical application of clotrimazole and betamethasone dipropionate cream is unlikely and would not be expected to lead to a life-threatening situation. Clotrimazole and betamethasone dipropionate cream should not be used for longer than the prescribed time period.

Topically applied corticosteroids, such as the one contained in clotrimazole and betamethasone dipropionate cream, can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Clotrimazole and Betamethasone Dipropionate Clotrimazole and betamethasone dipropionate cream has been shown to be at least as effective as clotrimazole alone in a different cream vehicle. Use of corticosteroids in the treatment of fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate. Clotrimazole Skin penetration and systemic absorption of clotrimazole following topical application of clotrimazole and betamethasone dipropionate cream have not been studied.

The following information was obtained using 1% clotrimazole cream and solution formulations. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm 3 in the stratum corneum, to 0 . 5 to 1 mcg/cm 3 in the reticular dermis, and 0 .

1 mcg/cm 3 in the subcutis. No measurable amount of radioactivity (<0 . 001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0 .

5 mL of the solution or 0 . 8 g of the cream. Only 0 .

5% or less of the applied radioactivity was excreted in the urine. Microbiology Mechanism of Action: Clotrimazole is an imidazole antifungal agent. Imidazoles inhibit 14-(-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes.

This leads to the accumulation of 14-(-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 Vivo: Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum .

Activity In Vitro: In vitro , clotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this information is unknown . 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 . Betamethasone Dipropionate Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. Pharmacokinetics: 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 (see DOSAGE AND ADMINISTRATION section).

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 section).

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. Studies performed with clotrimazole and betamethasone dipropionate cream indicate that this topical combination antifungal/corticosteroid may have vasoconstrictor potencies in a range that is comparable to high potency topical corticosteroids. Therefore, use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion.

📦 How Supplied / Storage and Handling 79 words ▾

HOW SUPPLIED Clotrimazole and Betamethasone Dipropionate Cream USP is supplied as follows: 15 gram tube in a carton (NDC 63187-095-15) 45 gram tube in a carton (NDC 63187-095-45) Store at 25°C (77(F); excursions permitted to 15(-30(C (59(-86(F) [See USP Controlled Room Temperature]. Manufactured by Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA FORM NO. 0379 Rev.

9/08 VC3206 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

📋 Description 195 words ▾

DESCRIPTION Clotrimazole and Betamethasone Dipropionate Cream USP contains a combination of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use. Chemically, clotrimazole is 1-( o -chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C 22 H 17 ClN 2 , a molecular weight of 344 . 84, and the following structural formula: Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.

Betamethasone dipropionate has the chemical name 9-fluoro-11(,17,21-trihydroxy-16(-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504 . 59, and the following structural formula: 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 and 0 .

643 mg betamethasone dipropionate (equivalent to 0 . 5 mg betamethasone), in a hydrophilic cream. INACTIVE INGREDIENTS Cetereath-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.

Clotrimazole and betamethasone dipropionate cream is smooth, uniform, and white to off-white in color. T:\Maryland\Published\Semi-Solids\Clotrimazole and Betamethasone Dipropionate Cream USP Rev.4-08\formula1.jpg T:\Maryland\Published\Semi-Solids\Clotrimazole and Betamethasone Dipropionate Cream USP Rev.4-08\formula2.jpg

💬 Information for Patients ~1 min read ▾

Information for Patients Patients using clotrimazole and betamethasone dipropionate cream should receive the following information and instructions: • The medication is to be used as directed by the physician and is not recommended for use longer than the prescribed time period. It is for external use only. Avoid contact with the eyes, the mouth, or intravaginally. • 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. • This medication should only be used for the disorder for which it was prescribed. • Other corticosteroid-containing products should not be used with clotrimazole and betamethasone dipropionate without first talking with your physician. • The treated skin area should not be bandaged, covered, or wrapped so as to be occluded (see DOSAGE AND ADMINISTRATION ). • Any signs of local adverse reactions should be reported to your physician. • Patients should avoid sources of infection or reinfection. • When using clotrimazole and betamethasone dipropionate cream in the groin area, patients should use the medication for two weeks only, and apply the cream sparingly.

Patients should wear loose-fitting clothing. Notify the physician if the condition persists after two weeks. • The safety of clotrimazole and betamethasone dipropionate cream has not been demonstrated in the treatment of diaper dermatitis. Adverse events consistent with corticosteroid use have been observed in patients treated with clotrimazole and betamethasone dipropionate cream for diaper dermatitis.

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

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings.

Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. Patients applying clotrimazole and betamethasone dipropionate cream to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression. This may be done by using the ACTH stimulation, morning plasma cortisol, and urinary-free cortisol tests.

If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA-axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

In a small study, 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 eight 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 Cortrosyn test.

The effect on morning plasma cortisol was transient and subjects recovered one week after discontinuing dosing. In addition, two separate studies in pediatric patients demonstrated adrenal suppression as determined by cosyntropin testing (see PRECAUTIONS – Pediatric Use section). Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS – Pediatric Use section).

If irritation develops, clotrimazole and betamethasone dipropionate cream should be discontinued and appropriate therapy instituted. THE SAFETY OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM HAS NOT BEEN DEMONSTRATED IN THE TREATMENT OF DIAPER DERMATITIS. ADVERSE EVENTS CONSISTENT WITH CORTICOSTEROID USE HAVE BEEN OBSERVED IN PATIENTS TREATED WITH CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM FOR DIAPER DERMATITIS.

THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM IN THE TREATMENT OF DIAPER DERMATITIS IS NOT RECOMMENDED. Information for Patients Patients using clotrimazole and betamethasone dipropionate cream should receive the following information and instructions: • The medication is to be used as directed by the physician and is not recommended for use longer than the prescribed time period. It is for external use only.

Avoid contact with the eyes, the mouth, or intravaginally. • 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. • This medication should only be used for the disorder for which it was prescribed. • Other corticosteroid-containing products should not be used with clotrimazole and betamethasone dipropionate without first talking with your physician. • The treated skin area should not be bandaged, covered, or wrapped so as to be occluded (see DOSAGE AND ADMINISTRATION ). • Any signs of local adverse reactions should be reported to your physician. • Patients should avoid sources of infection or reinfection. • When using clotrimazole and betamethasone dipropionate cream in the groin area, patients should use the… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 69 words ▾

Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroids production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could 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 is administered to a nursing woman.

🔬 Clinical Studies 117 words ▾

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

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

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.

This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1 . 0 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 1-8 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.

📄 Patient Package Insert ~3 min read ▾

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USP Rx Only Patient Information Leaflet What is Clotrimazole and Betamethasone Dipropionate Cream? Clotrimazole and Betamethasone Dipropionate Cream is a medication used on the skin to treat fungal infections of the feet, groin and body, as diagnosed by your doctor. Clotrimazole and Betamethasone Dipropionate Cream should be used for fungal infections that are inflamed and have symptoms of redness and/or itching.

Talk to your doctor if your fungal infection does not have these symptoms. Clotrimazole and Betamethasone Dipropionate Cream contains a corticosteroid. Notify your doctor if you notice side effects with the use of Clotrimazole and Betamethasone Dipropionate Cream (see “What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream?” below).

Clotrimazole and Betamethasone Dipropionate Cream is not to be used in the eyes, in the mouth, or in the vagina. How does Clotrimazole and Betamethasone Dipropionate Cream work? Clotrimazole and Betamethasone Dipropionate Cream is a combination of an antifungal agent (clotrimazole) and a corticosteroid (betamethasone dipropionate).

Clotrimazole works against fungus. Betamethasone dipropionate, a corticosteroid, is used to help relieve redness, swelling, itching, and other discomforts of fungal infections. Who should NOT use Clotrimazole and Betamethasone Dipropionate Cream?

Clotrimazole and Betamethasone Dipropionate Cream is not recommended for use in patients under the age of 17 years. Clotrimazole and Betamethasone Dipropionate Cream is not recommended for use in diaper rash. Patients who are sensitive to clotrimazole and betamethasone dipropionate, other corticosteroids or imidazoles or any ingredients in the preparation should not use Clotrimazole and Betamethasone Dipropionate Cream.

How should I use Clotrimazole and Betamethasone Dipropionate Cream? Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream into the affected and surrounding skin areas twice a day, in the morning and evening. Treatment for 2 weeks on the groin or on the body, and for 4 weeks on the feet is recommended.

The use of Clotrimazole and Betamethasone Dipropionate Cream for longer than 4 weeks is not recommended for any condition. Prolonged use of Clotrimazole and Betamethasone Dipropionate Cream may lead to unwanted side effects. What other important information should I know about Clotrimazole and Betamethasone Dipropionate Cream? • This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved.

Notify your doctor if there is no improvement after 1 week of treatment on the groin or body or after 2 weeks on the feet. • This medication should only be used for the disorder for which it was prescribed. • The treated skin area should not be bandaged or otherwise covered or wrapped. • Other corticosteroid-containing products should not be used with Clotrimazole and Betamethasone Dipropionate without first talking with your physician. • Any signs of side effects where Clotrimazole and Betamethasone Dipropionate Cream is applied should be reported to your doctor. • When using Clotrimazole and Betamethasone Dipropionate Cream in the groin area, it is especially important to use the medication for 2 weeks only, and to apply the cream sparingly.

You should tell your doctor if your problem persists after 2 weeks. You should also wear loose-fitting clothing so as to avoid tightly covering the area where Clotrimazole and Betamethasone Dipropionate Cream is applied. • This medication is not recommended for use in diaper rash. What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream?

The following side effects have been reported with topical corticosteroid medications: itching, irritation, dryness, infection of the hair follicles, increased hair, acne, fragile blood vessels, sensitization (local reactions upon repeated applications of product),… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 63187-095-45

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (63187-0095-45). Each has its own NDC and its own page — see the package list near the top of this page.
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Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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