TOLNAFTATE- antifungal liquid maximum strength liquid

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America, 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 corporis)
• prevents the recurrences of 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 under 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 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

Water, Acrylates Copolymer, Glycerin (RSPO), Phenoxyethanol, Tocopherol, Sodium Hydroxide, Ethylhexyglycerin

Questions?

Call 1-866-964-0939

Principal Display Panel

Premier

MAXIMUM

STRENGTH

ANTIFUNGAL

LIQUID

Tolnaftate 1%

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 appplication

NET WT 1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
antifungal liquid maximum strength liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-242
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
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: 56104-242-01	30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	03/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/05/2021

Labeler - Premier Brands of America, Inc. (063849780)