TOLNAFTATE- foot odor control 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

• prevents recurrence of athlete's foot (tinea pedis) with daily use
• cures mose athlete's foot (tinea pedis) and ringworm (tinea corporis)
• relieves sypmtoms of athlete's foot, including itching, burning and cracking

Warnings

​For external use only.

​Flammable:

Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate.  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

​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)
• in case of clogging, clear nozzle under running water

​Other information

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

​Inactive ingredients

disteardimonium hectorite, fragrance, isobutane, isopropyl myristate, SD alcohol 40-B, sodium bicarbonate

Questions?

call 1-866-964-0939

Principal Display Panel

CareOne

Foot Odor Control Spray

Antifungal Powder Spray

Tolnaftate

Cures Most Athlete's Foot and Prevents Recurrence

Reduces Foot Odor

Relieves Itching, Burning and Cracking

NET WT 4 OZ (113g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
foot odor control spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.13 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALCOHOL (UNII: 3K9958V90M)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-086-04	113 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)