OTC Medication Information: Tolnaftate

TOLNAFTATE- tolnaftate liquid
LEADER/ Cardinal Health 110, Inc.

​Active ingredient

Tolnaftate 1% w/w

​Purpose

Antifungal

Uses

proven clinically effective in the treatment of athlete’s foot (tinea pedis) and ringworm (tinea corportis)

prevents the recurrences of most athlete’s foot with daily use

for effective relief of itching, burning, cracking, redness and scaling

Warnings

For external use only.

Do not use

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

When using this product

avoid contact with eyes.

Stop use and consult a doctor if

  • irritation occurs
  • there is no improvement in 4 weeks

Keep out of reach of children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

​Directions

Read all warnings and directions. Use only as directed.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the 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 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 longer, consult a doctor
  • to prevent athlete’s foot: wash the feet thoroughly, apply 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

​Other information

  • store at room temperature 15°-30°C (59° — 86°F)
  • protect from freezing. If freezing occurs warm to room temperature
  • keep tightly closed when not in use

​Inactive ingredient

Acrylates Copolymer, Ethylhexyglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide,Tocopherol, Water.

Questions?

Call 1-866-964-0939

Principal Display

Leader

Maximum Strength

Antifungal

Liquid

TOLNAFTATE 1%

MEDICATED

ANTIFUNGAL

  • Proven clinically effective in the cure & prevention of fungus on fingers, toes & around nails
  • Relieves itching, burning & scaling
  • With moisturizer
  • Built-in brush for easy application

NET WT 1 FL OZ (30 mL)

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TOLNAFTATE
anti-fungal liquid maximum strength liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0637
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOXYETHANOL
SODIUM HYDROXIDE
WATER
GLYCERIN
TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0637-1 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR
1 30 mL in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (70000-0637-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M005 05/18/2023
Labeler — LEADER/ Cardinal Health 110, Inc. (063997360)

Revised: 02/2024 LEADER/ Cardinal Health 110, 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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