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 Harmon Store Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• prevents recurrence of athlete's foot 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:

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 (68º and 86ºF)

Inactive ingredients

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

Questions?

call 1-866-964-0939

Principal Display Panel

Harmon FaceValues

Antifungal

Foot Odor Control Spray Powder

Tolnaftate 1%

Removes Odors

WITH BAKING SODA

Cures and Prevents Most

Athlete's Foot

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: 63940-011
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-011-40	113 g in 1 CAN; Type 0: Not a Combination Product	01/27/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/27/2012

Labeler - Harmon Store Inc. (804085293)