ANITFUNGAL FOOT CARE- tolnaftate spray
Rite Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most
athlete’s foot (tinea pedis)
ringworm (tinea corporis)
effectively soothes and relieves
itching
burning
cracking
helps prevent most athlete’s foot from coming back with daily use

Warnings

For external use only

Flammable: Do not use near flame or spark or while smoking.

Do not use

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

When using this product

avoid contact with the eyes
contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F (49°C).
use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks

Keep out of reach of children.

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

Directions

clean the affected area and dry thoroughly
shake can well before use
hold can about 6 inches from the area to be treated
spray a thin layer over the 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 condition lasts longer, ask a doctor.
to prevent athlete’s foot, apply to the feet once or twice daily (morning and/or night)
this product is not effective on the scalp or nails

Inactive ingredients

alcohol SD 40-B, butylated hydroxytoluene (BHT), isobutane, polyethylene glycol, polysorbate 20

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Tinactin® Antifungal Liquid Spray

Foot care

Antifungal

Liquid spray

Tolnaftate 1%

Cools and relieves itching & burning

Cures and prevents most athlete's foot

Antifungal Label

ANITFUNGAL FOOT CARE
tolnaftate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0154
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (TOLNAFTATE)	TOLNAFTATE	1 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE
POLYETHYLENE GLYCOL
POLYSORBATE 20

Packaging
#	Item Code	Package Description
1	NDC:11822-0154-1	150 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/24/2004

Labeler - Rite Aid Corporation (014578892)

Revised: 01/2010

Document Id: 6d10e8a2-dbdc-4ee6-b1ba-aadf631dc3e2

Set id: 6d10e8a2-dbdc-4ee6-b1ba-aadf631dc3e2

Version: 1

Effective Time: 20100108

Rite Aid Corporation