Clotrimazole 10 mg/mL
Clotrimazole topical · SOLUTION · Novitium Pharma LLC
Clotrimazole is a solution containing clotrimazole topical at 10 mg/mL, taken topical. Manufactured by Novitium Pharma LLC.
Key Facts
- Brand Name
- Clotrimazole
- Generic Name
- Clotrimazole topical
- NDC Code (Product)
70954-036- Manufacturer
- Novitium Pharma LLC
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA209815
- Drug Class
- Azole Antifungal [EPC]
- Marketing Start
- 02/18/2019
Recall History
Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Cherry Hill Sales Co.
CGMP Deviations
Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Glenmark Pharmaceuticals Inc., USA
Temperature Abuse: Complaints received of liquidy texture.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Dosage & Administration
Directions • Wash the affected area and dry thoroughly. ● Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor. ● Supervise children in the use of this product. ● For athlete’s foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily. ● For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. ● If conditions persists longer, consult a doctor. ● This product is not effective on the scalp or nails.
Warnings
Warnings For External use only.
Frequently Asked Questions
What is Clotrimazole used for?
Clotrimazole contains Clotrimazole topical. It is a solution taken topical. Consult your doctor for specific uses.
Is Clotrimazole a controlled substance?
Clotrimazole is not classified as a controlled substance by the DEA.
What is the generic name for Clotrimazole?
The generic name for Clotrimazole is Clotrimazole topical. There are 5 other brand versions of Clotrimazole topical.
What is the NDC code for Clotrimazole 10 mg/mL?
The NDC (National Drug Code) for Clotrimazole 10 mg/mL is 70954-036, listed by Novitium Pharma LLC.