Active Ingredient
Clotrimazole USP, 1.0%
Clotrimazole Antifungal Solution
FDA Label NDC 69396-143
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 Antifungal (NDC 69396-143). 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, uses, warnings, stop use and ask a doctor, ask a doctor before use, when using this product, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
Cures most
- Athlete's foot (tinea pedis)
- Jock Itch (Tinea Cruris)
- Ringwork (Tinea corporis)
- Itching
- Cracking
- Burning
Effectively relieves
Discomfort that can accompany these conditions
Warnings
For External Use Only
Stop Use And Ask A Doctor
- If irritation occurs
- If there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
Ask A Doctor Before Use
Ask a doctor before use on children under 2 years of age
When Using This Product
Avoid Contact with Eyes.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
- Spray over affected area
- If bandaged, let dry first
- Not to be used on children under 12 years of age
Other Information
- Store at controlled room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
Ethanol, Propylene glycol, purified water
Questions Or Comments
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA®
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
Globe® Clotrimazole anti-fungal solution is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®AF.
* Please review the disclaimer below.
