Clotrimazole/Betameth .5 mg/g
Clotrimazole/Betameth · CREAM · Direct_Rx
Clotrimazole/Betameth is a prescription cream containing clotrimazole/betameth at .5 mg/g, taken topical. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Clotrimazole/Betameth
- Generic Name
- Clotrimazole/Betameth
- NDC Code (Product)
72189-518- Manufacturer
- Direct_Rx
- Strength
- .5 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA076002
- Drug Class
- Azole Antifungal [EPC]; Azoles [CS]
- Marketing Start
- 10/25/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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.
Dosage & Administration
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.
Contraindications
None.
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 was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency less than 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 a…
Frequently Asked Questions
What is Clotrimazole/Betameth used for?
Clotrimazole/Betameth contains Clotrimazole/Betameth. It is a cream taken topical. Consult your doctor for specific uses.
Is Clotrimazole/Betameth a controlled substance?
Clotrimazole/Betameth is not classified as a controlled substance by the DEA.
What is the generic name for Clotrimazole/Betameth?
The generic name for Clotrimazole/Betameth is Clotrimazole/Betameth. There are no other listed brand versions of Clotrimazole/Betameth.
What is the NDC code for Clotrimazole/Betameth .5 mg/g?
The NDC (National Drug Code) for Clotrimazole/Betameth .5 mg/g is 72189-518, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)