Winco Foods Tolnaftate Cream
FDA Label NDC 67091-276

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Foods Tolnaftate (NDC 67091-276). 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, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each gram)  Purpose

Tolnaftate 1%--------------------------------------------------------------------------------- Antifungal

Otc - Purpose

Uses

  • Proven clinically effective in the treatment of athlete's foot (tinea pedis) and rignworm (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

Do not use on children under 2 years of age unless directed by a doctor

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

  • wash affected area and dry thoroguhly
  • 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

Other Safety Information

Other information

  • store between 20° to 25C° (68° to 77F°)
  • Lot No & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

buylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

Dosage & Administration

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN KOREA

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