TOLNAFTATE- foot odor control powder spray aerosol, spray

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Winco Foods, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• cures mose athlete's foot (tinea pedis) and ringworm (tinea corporis)
• prevents recurrence of athlete's foot with daily use
• relieves 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 above 120°F. Intentional misuse by deliberately concentrating and inhaling the 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) 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
• use daily for 4 weeks
• if conditions persists, 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
• if nozzle clogs, clear nozzle under running warm water until unclogged

Other information

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

Inactive ingredients

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

Questions?

Call 800-824-1706 Monday - Friday 9am - 4pm MST

Principal Display Panel

Odor Control

Foot

Powder

Spray

TOLNAFTATE 1%/

ANTIFUNGAL

Cures Most Athlete's Foot

& Reduces Foot Odor

Relieves Itching, Cracking & Burning

Talc-Free

NET WT 4 OZ (113g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
foot odor control powder spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.3 g  in 113 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-390-04	113 g in 1 CAN; Type 0: Not a Combination Product	09/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/29/2021

Labeler - Winco Foods, LLC (056098817)