LAMISIL AF DEFENSE SHAKE- tolnaftate powder 
Novartis Consumer Health, Inc.

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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Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • Proven clinically effective in the treatment of most athlete’s foot (tinea pedis), and ringworm (tinea corporis)
  • Clinically proven to prevent most athlete’s foot with daily use
  • For effective relief of itching, burning and cracking

Warnings

For external use only

Do not use

  • in children under 2 years of age unless directed by a doctor

When using this product

  • avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs or gets worse
  • 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

  • adults and children 2 years of age and older
    • wash the affected area and dry thoroughly
    • apply 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 condition persists longer, ask 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.

Other information

  • store at controlled room temperature 150C to 250C (590F to 770F)
  • see container bottom for lot number and expiration date

Inactive ingredients

corn starch, fragrance, talc

Questions or comments?

call 1-800-452-0051

Additional information listed on other panels

Distributed by:
Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
©2011

www.lamisilat.com

PRODUCT PACKAGED BY WEIGHT NOT VOLUME

Principal Display

NDC 0067-6113-04

Lamisil AF
Defense®
Tolnaftate 1%, Antifungal

Shake Powder

Prevents Most Athlete’s Foot

Lamisil Defense Shake Powder 4 oz. Label

LAMISIL AF  DEFENSE SHAKE
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-6113
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TALC 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6113-04113 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/200607/31/2013
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 3/2014
 
Novartis Consumer Health, Inc.