ATHLETES FOOT- tolnaftate solution/ drops

Athletes Foot by

Drug Labeling and Warnings

Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Imperial Feet B.V., Creative Essences Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

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.

Ask a doctor

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

Stop Use

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

Inactive Ingredient

Inactive Ingredients Almond Oil, Alpha-Bisabolene,
Calendula Officinalis Flower, Chamomile, Chlorphenesin,
Glycerin, Methyl-Gluceth-20, Phenoxyethanol, Piroctone
Olamine, Polysorbate 20, Polyethylene Glycol 400,
Polyoxyl 40 Hydrogenated Castor Oil, Squalene, Water

Other Information

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

Purpose

Antifungal

Directions

• Wash the affected area and dry thoroughly.
• Apply a thin layer of the product over affected area 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 the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
• If condition persists longer, consult a doctor.

Keep out of reach of children

Supervise children in the use of this product

Use

Cures most Athlete's Foot

Principal Display Panel / Product Label

INGREDIENTS AND APPEARANCE

ATHLETES FOOT 
tolnaftate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83837-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.3 g  in 100 mL
CHLORPHENESIN (UNII: I670DAL4SZ)	0.2 g  in 100 mL
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)	0.05 g  in 100 mL
ALMOND OIL (UNII: 66YXD4DKO9)	1 g  in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	13 g  in 100 mL
WATER (UNII: 059QF0KO0R)	0.3 g  in 100 mL
SQUALENE (UNII: 7QWM220FJH)	0.1 g  in 100 mL
METHYL GLUCETH-20 (UNII: J3QD0LD11P)	3 g  in 100 mL
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)	0.1 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.75 g  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.1 g  in 100 mL
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)	0.3 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	70 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.3 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83837-002-01	75 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/19/2024

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

Labeler - Imperial Feet B.V. (386790021)

Registrant - Creative Essences Inc (079120182)

Establishment
Name	Address	ID/FEI	Business Operations
Creative Essences Inc		079120182	manufacture(83837-002)