OTC Medication Information: Tolnaftate

TOLNAFTATE- tolnaftate spray
VALU MERCHANDISERS, CO

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)
  • ringworm (tinea corporis)
  • effectively soothes and relieves
  • itching
  • burning
  • cracking
  • helps prevent most athlete’s foot from coming back with daily use

Warnings

For external use only

Flammable: Do not use near flame or spark or while smoking.

Do not use

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

When using this product

  • avoid contact with the eyes
  • contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F (49°C).
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children.

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

Directions

  • clean the affected area and dry thoroughly
  • shake can well before use
  • hold can about 6 inches from the area to be treated
  • spray a thin layer over the 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 lasts longer, ask a doctor.
  • to prevent athlete’s foot, apply to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
  • in case of clogging, clean nozzle with a pin

Inactive ingredients

alcohol SD 40-B, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propane, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

Questions or comments?

1-800-719-9260

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Best Choice

Athlete’s Foot

Antifungal

Powder Spray

Tolnaftate 1%

Cures & prevents most athlete’s foot

Relieves itching & burning

NET WT 4.6 OZ (130g)

//otclabels.com/lib/images-otc/tolnaftate-17/best-choice_antifungal-tolnaftate-powder-spray_laptsbc-2-300x220.jpg
(click image for full-size original)
TOLNAFTATE
tolnaftate athletes foot powder spray spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-555
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1.3 g in 130 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ISOBUTANE
PPG-12-BUTETH-16
ALCOHOL
TALC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63941-555-46 130 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 12/12/2017
Labeler — VALU MERCHANDISERS, CO (868703513)

Revised: 07/2021 VALU MERCHANDISERS, CO

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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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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