Active Ingredient
Clotrimazole USP 1% w/w
Clotrimazole Cream
FDA Label NDC 69396-038
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Clotrimazole (NDC 69396-038). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, otc - keep out of reach of children, uses, warnings, stop use and ask a doctor if:, if pregnant or breastfeeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal Cream
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Uses
Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, burning, cracking, scaling and discomfort which can accompany these conditions.
Warnings
● Do not use on children under 2 years of age except under the advice of a doctor.
● For external use only
● When using this product avoid contact with eyes.
Stop Use And Ask A Doctor If:
- irritation occurs
- there is no improvement within 4 weeks (for Athlete's foot or ringwork) or within 2 weeks (for jock itch).
If Pregnant Or Breastfeeding
If Pregnant or breastfeeding, ask a health professional before use.
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.
Inactive Ingredients
Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water
Other Information
- store at controlled room temperature 20°-25°C (68°- 77°F)
- Close cap tightly after use.
Questions Or Comments?
Call 1-888-296-9067 Mon-Fri 9AM - 5PM
DISTRIBUTED BY: MIDWOOD BRANDS, LLC.
500 Volvo Parkway, Chesapeake, VA. 23320
NOT SATISFIED?
Return Package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.
This product is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®
* Please review the disclaimer below.
