TOLNAFTATE- anti-fungal liquid maximum strength liquid

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Hudson Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• prevents the recurrence 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 within 4 weeks

Keep out of children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center 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 conditions persists longer, consult a doctor
• to prevent athlete's foot: wash the feet and dry 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, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide, Tocopherol, Water

Questions?

Call 1-877-237-0194

Principal Display Panel

comfortzone

maximum strength

anti-fungal liquid

tolnaftate 1%

Proven clinically effective in the cure and prevention of fungus on fingers, toes & around nails

• relieves itching burning & scaling
• with moisturizer
• built-in brush for easy application
• 1 FL. OZ (30mL)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
anti-fungal liquid maximum strength liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72446-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.3 g  in 30 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72446-011-01	30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/21/2021	06/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/21/2021	06/20/2025

Labeler - Hudson Health LLC (081276171)