LAMISL AF DEFENSE- tolnaftate cream 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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

Purpose

Antifungal

Uses

treats and prevents most athlete’s foot (tinea pedis), and ringworm (tinea corporis)
prevents most athlete’s foot (tinea pedis) with daily use
relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor
in or near the mouth or the eyes
on nails or scalp 

When using this product

do not get into eyes. If eye contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation occurs or gets worse
no improvement in athlete’s foot 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 over
to open tube, peel off foil seal
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
for athlete’s foot pay special attention to spaces between the toes
wear well-fitting, ventilated shoes
change shoes and socks at least once daily
use daily for 4 weeks; if condition persists longer, consult a doctor
to prevent athlete’s foot, apply once or twice daily (morning and/or night)
supervise children in the use of this product
wash hands after each use
children under 2 years of age: as a doctor

Other information

do not use if seal on tube is broken or is not visible
store at controlled room temperature 200C- 250C (680F- 770F)

Inactive ingredients

acrylates/C10-30 acrylate cross polymer, carbomer, corn starch, cyclomethicone, edetate disodium, ethyl alcohol, fragrance, isopropyl mysristate, propylene glycol, purified water, strong ammonia solution

Questions or comments?

call 1-800-452-0051

 

 Distr. By: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008

Principal Display

Lamisil AF Defense
LAMISL AF  DEFENSE
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6266
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6266-301 in 1 CARTON01/01/201003/31/2015
130 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201003/31/2015
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 7/2019
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC