Active ingredient

Tolnaftate

Ask a doctor

If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor

Purpose

Antifungal

Use

Cures most fungus on toes

Keep out of reach of children

Supervise children in the use of this product.

Stop Use Section

If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Directions

Wash the affected area and dry thoroughly.
Apply a thin layer of the product over affected are twice daily (morning and night) or as directed by a doctor.
Supervise children in the use of this product.
Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
If condition persists longer, consult a doctor.

Warnings

Do not use on children under 2 years of age unless directed by a doctor.
For external use only.
Avoid contact with the eyes.
If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Other Information

Store between 20 C and 30 C (68 F and 86 F)

Inactive Ingredients

Alpha-Bisabolene, Chlorphenesin, Glycerin, Horse Chestnut, Jojoba Oil, Methyl Gluceth-20, Phenoxyethanol, Piroctone Olamine, Polyethylene Glycol 400, Polyoxyl 40 Hydrogenated Castor Oil, Squalene, Tea Tree Oil, Water

Principle Display Panel

Version 3

TOE FUNGUS
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83837-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SQUALENE (UNII: 7QWM220FJH)	0.1 g in 100 mL
WATER (UNII: 059QF0KO0R)	0.3 g in 100 mL
.ALPHA.-BISABOLENE (UNII: SUQ209P6FX)	0.1 g in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.6 g in 100 mL
METHYL GLUCETH-20 (UNII: J3QD0LD11P)	3 g in 100 mL
JOJOBA OIL (UNII: 724GKU717M)	0.3 g in 100 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ)	0.1 g in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	78 mL in 100 mL
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)	0.05 g in 100 mL
CHLORPHENESIN (UNII: I670DAL4SZ)	0.12 g in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	15 g in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.365 g in 100 mL
TEA TREE OIL (UNII: VIF565UC2G)	0.3 g in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83837-001-01	75 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/19/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	02/19/2024

Labeler - Imperial Feet B.V. (386790021)

Imperial Feet Toe Fungus 83837-001-01