Athletes Foot Cream
FDA Label NDC 55910-341

13 label sections · Submitted to the FDA by Dollar General · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dollar General for the product Athletes Foot (NDC 55910-341). 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, otc - do not use, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

DISTRIBUTED BY OLD EAST MAIN CO.,
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • prevents the recurrence of most athlete's foot with daily use
  • relieves itching, burning, cracking, scaling, and discomfort that accompany these conditions

Otc - Do Not Use

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

For external use only.

Avoid contact with eyes.

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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: 800-222-1222.

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in 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
  • this product is not effective on scalp or nails

Other Information

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Questions Or Comments?

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Compare to the active
ingredient of TINACTIN®*

Athlete's Foot Cream
Antifungal Cream

NET WT 1 OZ (28 g)

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Principal Display Panel (28 g Tube Carton)

* Please review the disclaimer below.