OTC Medication Information: Tolnaftate

TOLNAFTATE- tolnaftate aerosol, spray
Meijer Distribution Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
  • prevent recurrence of most athlete’s foot with daily use
  • for effective relief of itching, cracking and burning

Warnings

For external use only.

Flammable:

Contents under pressue. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container. Do not store at temperature above 120F. Keep out of reach of children. Use only as directed. Intentional misuse by dilberately concentrating and inhaling the contents can be harmful or fatal.

When using this product

avoid contact with the eyes or mouth

use only as directed

Stop use and ask a doctor if

irritation occurs

no improvement within 4 weeks for athlete’s foot and ringworm

Do not use

on children under 2 years of age unless directed by a doctor.

Keep out of reach od children.

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

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray 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, and change shoes and socks at least once daily
  • for athlete’s foot and ringworm, use daily for 4 weeks
  • if condition persists, consult a doctor
  • to prevent athlete’s foot: wash the feet and dry thoroughly; spray a thin layer of the product to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
  • if nozzle clogs, clean with a pin

​Other information

store between 20º and 30ºC (68º and 86ºF)

​Inactive ingredients

BHT, isobutane, PPG-12-buteth-16, SD alcohol 40-B

​Questions?

Call 800-824-1706 Monday — Friday 9am — 4pm MST

Principal Display Panel

Antifungal

Liquid Spray

Tolnaftate 1%/

ANTIFUNGAL

  • Cures Most Athlete’s Foot & Prevents Recurrences
  • Relieves Itching, Cracking & Burning

NET WT 5.3 OZ (150g)

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TOLNAFTATE
meijer athletes foot liquid spray aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0591
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1.5 g in 150 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ISOBUTANE
PPG-12-BUTETH-16
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79481-0591-1 150 g in 1 CANISTER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 03/11/2022
Labeler — Meijer Distribution Inc. (006959555)

Revised: 04/2022 Meijer Distribution Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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