TOLNAFTATE- antifungal spray liquid aerosol, spray

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by FSA Store Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of 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, cracking and burning

Warnings

For external use only.

​Flammable:

Contents under pressure. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container.Do not store at temperature above 120ºF. Keep out fo reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

• avoid contact with the eyes or mouth
• use only as directed

​Stop use and ask a doctor if

• irritation occurs
• no improvement within 4 weeks for athlete's foot and ringworm.

​Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer over 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 the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• for athlete's foot and ring worm, use daily for 4 weeks
• if condition persists, consult a doctor
• to prevent athlete's foot: wash the feet and dry thoroughly; spray 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
• if nozzle clogs, clear with a pin

​Other information

store between 20º and 30ºC (68º and 86ºF)

​Inactive ingredients

BHT, isobutane, PPG-12-buteth-16, SD alcohol 40-B

​ ​Questions?

Call 1-866-964-0939

​Principal Display Panel

caring mill​

Antifungal

Athlete's Foot

Liquid Spray

Antifungal/Tolnaftate 1%

Cures most athlete's foot and prevents recurrences

Relieves itching, cracking and burning

Net WT 5.3 OZ. (150g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
antifungal spray liquid aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81522-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.15 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOBUTANE (UNII: BXR49TP611)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81522-078-01	150 g in 1 CAN; Type 0: Not a Combination Product	05/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/08/2023

Labeler - FSA Store Inc. (049283340)