Your browser does not support JavaScript! FOOT WORKS HEALTHY ANTIFUNGAL (TOLNAFTATE) POWDER [AVON PRODUCTS, INC.]
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FOOT WORKS HEALTHY ANTIFUNGAL (tolnaftate) powder
[Avon Products, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient
Tolnaftate 1.0%.........................

         Purpose
.......................Antifungal

Uses
• proven clinically effective in the treatment of most athlete’s foot (tinea pedis)
• relieves itching, burning feet
• prevents the recurrence of most athlete’s foot (tinea pedis) with daily use

Warnings
For external use only

Do not use
• on children under 2 years of age unless directed by a doctor

When using this product
• avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if
• irritation occurs or if 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
• To treat athlete’s foot, clean the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Use daily for 4 weeks. If condition persists longer, consult a doctor. Not effective for infections of the nails or scalp.

• To prevent athlete’s foot, clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
• Supervise children in the use of this product.
• Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, cotton socks, and change shoes and socks at least once daily.

Inactive ingredients
TALC, ZINC OXIDE, SODIUM SILICOALUMINATE, TRICALCIUM PHOSPHATE, METHYLPARABEN, SODIUM POLYACRYLATE, WATER/EAU.

QUESTIONS? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada

IMAGE OF LABELIMAGE OF DFBIMAGE OF DFB

FOOT WORKS HEALTHY  ANTIFUNGAL
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10096-0303
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE ) TOLNAFTATE 10 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-0303-174 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/24/2013
Labeler - Avon Products, Inc. (001468693)

Revised: 4/2013
 
Avon Products, Inc.

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