Active Ingredient
Tolnaftate 1%
Tolnaftate Cream 1% Cream
FDA Label NDC 68016-152
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc. for the product Tolnaftate Cream 1% (NDC 68016-152). 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 ingredient, purpose, uses, keep out of the reach of children, warnings, directions, stop use and ask a doctor if, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Fungal
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
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Warnings
For External Use Only
When using this product avoid contact with the eyes
Do not use on children under 2 years of age except under the advice and supervision of a doctor
Directions
- 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
- Use daily for 4 weeks; if condition persists longer, ask 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
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 4 weeks
Other Information
- Store between 20° to 25°C (68° to 77°F)
- Lot No & Expiration Date: See box or crimp of tube
Inactive Ingredients:
Cetyl alcohol, Ethylparabe, Glycerol, Glyceryl Monostearate, Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl sulfate
Soothes Itching, Burning And Cracking
Distributed By:
Pharmacy Value Alliance, LLC.
407 East Lancaster Avenue, Wayne, PA. 19087 USA
www.emersongroup.com
* Please review the disclaimer below.
