Otc - Active Ingredient
Clotrimazole 1%
Athlete S Foot Antifungal Cream
FDA Label NDC 84763-020
11 label sections · Submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Athlete S Foot Antifungal Cream (NDC 84763-020). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Otc - Purpose
Antifungal
Indications & Usage
cures most athlete's foot, jock itch and ringworm.
relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
Warnings
For external use only
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
Ask a doctor before use if you have highly sensitive or allergic skin.
Ask a doctor or pharmacist before use if you are pregnant or breastfeeding
avoid contact with the eyes
external use only
Otc - Stop Use
irritation occurs
there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch.
Otc - Keep Out Of Reach Of Children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
wash the affected area and dry thoroughly; apply a thin layer over affected area twice daily, morning and night.
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. 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. If the condition persists longer, consult a doctor. This product is not effective on the scalp or nails. Supervise children in the use of this product.
Inactive Ingredient
Water
Glycerin
Sorbitol
Isononyl Isononanoate
Petrolatum
Hydrogenated Polyisobutene
Cetearyl Glucoside
Cetearyl Alcohol
Dimethicone
Butyrospermum Parkii (Shea) Butter Extract
Betaine
Glyceryl Stearate
PEG-100 Stearate
C10-30 Cholesterol/Lanosterol Esters
Phenoxyethanol
Tocopheryl Acetate
Carbomer
Triethanolamine
Allantoin
Menthol
Thymol
Borneol
Salicylic Acid
Ethylhexylglycerin
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Label (Label)
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