TOLNAFTATE- antifungal liquid spray aerosol, spray

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Foodhold USA. 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 recurrence of athlete's foot with daily use
• for effective relief of itching, cracking and burning

​Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans 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

Do not use

on children under 2 years of age unless directed by a doctor.

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)
• 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
• use daily for 4 weeks
• if conditions persist, consult a doctor
• to prevent athlete's foot, apply once or twice daily (morning and/or night)
• this product is not effective on the scalp or nails

​Other information

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

​Inactive ingredients

BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B(36%w/w)

Questions?

call 1-888-423-0139

​Principal Display Panel

CareOne

Antifungal

Athlete's Foot

Liquid Spray
Tolnaftate

Cures Most Athlete's Foot and Prevents Recurrence

Relieves Itching, Cracking and Burning

NET WT 5.3 OZ (150g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
antifungal liquid spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.5 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: 41520-082-53	150 g in 1 CAN; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/19/2017

Labeler - Foodhold USA (809183973)