Otc - Active Ingredient
Active ingredient Purpose
Tolnaftate 1%..................................................................Antifungal
Family Care Antifungal Cream
FDA Label NDC 65923-021
10 label sections · Submitted to the FDA by United Exchange Corp. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Antifungal (NDC 65923-021). 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 - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, 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 - When Using
When using this product avoid contact with the eyes
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
Otc - Keep Out Of Reach Of Children
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Indications & Usage
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; 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
Storage And Handling
Other information
- store between 20° to 25°C (68° to 77°F)
- Lot No. & Exp. Date: see box or see crimp of tube
Inactive Ingredient
Inactive ingredients
cetostearly alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodium sulfite, stearth-20, stearic acid
Dosage & Administration
Distributed by:
United Exchange Corp.
5836 Corporate Ave.
Cypress, CA 90630 USA
1-800-814-8028
Made in China
* Please review the disclaimer below.
