Clotrimazole 1 g/100g
Family Wellness Clotrimazole · CREAM · Trifecta Pharmaceuticals USA LLC
Clotrimazole is a cream containing family wellness clotrimazole at 1 g/100g, taken topical. Manufactured by Trifecta Pharmaceuticals USA LLC.
Key Facts
- Brand Name
- Clotrimazole
- Generic Name
- Family Wellness Clotrimazole
- NDC Code (Product)
69396-038- Manufacturer
- Trifecta Pharmaceuticals USA LLC
- Strength
- 1 g/100g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- M005
- Drug Class
- Azole Antifungal [EPC]
- Marketing Start
- 08/30/2019
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
Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
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%.
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 Family Wellness Clotrimazole. It is a cream 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 Family Wellness Clotrimazole. There are no other listed brand versions of Family Wellness Clotrimazole.
What is the NDC code for Clotrimazole 1 g/100g?
The NDC (National Drug Code) for Clotrimazole 1 g/100g is 69396-038, listed by Trifecta Pharmaceuticals USA LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)