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Drug Facts
Theracare Antifungal Cream
FDA Label NDC 71101-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Antifungal Cream (NDC 71101-017). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Tolnaftate 1%
Purpose
Antifungal
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
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
When using this productavoid contact with the eyes
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 4 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
adults and children 2 years of age and over:
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- 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
- to prevent athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
Children under 2 years of age: consult a physician
Other Information
store between 20° to 25°C (68° to 77°F)
- do not use if tube seal under cap is broken
Inactive Ingredients
ceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, propylene glycol, sodium matabisulfite, water
Questions?
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