Antifungal Cream Tolnaftate 1%
FDA Label NDC 79481-0015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer for the product Antifungal Cream Tolnaftate 1% (NDC 79481-0015). 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 drug facts, active ingredient, purpose, otc - keep out of reach of children, uses, warnings, when using this product, do not use, 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
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.
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.
When Using This Product
Avoid contact with the eyes
Do Not Use
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
If Pregnant Or Breast-Feeding
If Pregnant or Breast-feeding ask a health professional before use
Inactive Ingredients
Cetostearyl alcohol, ethylparaben, glycerol, mineral oil, glyceryl monostearate, petrolatum, purified water, sodium lauryl sulfate
Directions
● wash affected area and dry thoroughly
● apply a thin layer 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 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.
Other Information
● store between 20° to 25°C ( 68° to 77°F)
Questions Or Comments?
1-888-296-9067
Distributed By
Distrubuted By Meijer Distribution, Inc.
Grand Rapids, MI 49544
www.meijer.com
Made in China
This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademarks Tough Actin and Tinactin.
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