Active Ingredients
Clotrimazole 1%
Anti Fungal
FDA Label NDC 71582-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ertiantang Pharmaceutical Co.,ltd for the product Anti Fungal (NDC 71582-001). 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 ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, when use this product, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Coltrimazole 1% Antifungal
Uses
• For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis).
• For relief of itching, scaling, burning and discomfort that accompany these conditions.
Warnings
For External Use Only.
Do Not Use
On children under 2 years of age unless directed by a doctor.
Stop Use And Ask A Doctor If
• Irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot).
• If irritation occurs or if there is no improvement within 4 weeks (for jock itch).
• If condition persists longer, consult a doctor.
When Use This Product
• Avoid contact with the eyes.
• This product is not effective on the scalp or nails.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Clean the affected area and dry thoroughly. Apply a thin layer of the 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 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.
Storage
Store in cool, dry place away from direct sunlight.
Inactive Ingredients
GLACIAL ACETIC ACID, GARLIC OIL, OSTHOL, SOPHORA FLAVESCENS ROOT, PSEUDOLARIX AMABILIS BARK，PHRYMA LEPTOSTACHYA WHOLE, PHELLODENDRON CHINENSE WHOLE
Drug Facts
Image Description (Carton)
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