TOLNAFTATE- anti-fungal liquid maximum strength liquid

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by LEADER/ Cardinal Health 110, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​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)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
anti-fungal liquid maximum strength liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0637
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0637-1	1 in 1 CARTON	05/18/2023	05/30/2025
1		30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/18/2023	05/30/2025

Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)