Tolnaftate Cream
FDA Label NDC 24385-032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Tolnaftate (NDC 24385-032). 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, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

Otc - Do Not Use

For external use only

Ask A Doctor Before Use

  • on children under 2 years of age

When Using This Product

  • avoid contact with eyes

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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.

Directions

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product 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; change shoes and socks at least once daily

Other Information

  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Questions?

Call 1-866-923-4914

Principal Display Panel - 30 G Tube Carton

GOOD
NEIGHBOR
PHARMACY®

Compare to the Tinactin® active ingredient*

NDC 24385-032-03

Tolnaftate 1% Cream
Antifungal Cream

Cures & Prevents Most Athlete's Foot

NET WT 1 oz (30 g)

Principal Display Panel (30 g Tube Carton)

Principal Display Panel (30 g Tube Carton)

* Please review the disclaimer below.