Otc - Active Ingredient
Active ingredient Purpose
Tolnaftate 1%..................................................................Antifungal
Cvs Health Athletes Foot Cream
FDA Label NDC 69842-336
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Health Athletes Foot (NDC 69842-336). 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, warnings, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
- helps prevent most athlete's foot with daily use
- for effective relief of itching, burning and cracking
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use on children under 2 years of age except under the advice and supervision of a doctor
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Indications & Usage
Directions
- wash 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. If condition persists longer, consult a doctor
- to prevent athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
cetostearyl alcohol, ethylparaben, glycerin, glyceryl, monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid
Dosage & Administration
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
Package Label.Principal Display Panel
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