TOLNAFTATE - tolnaftate cream 
LIFElabs, a Division of Atico International, USA, 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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LIFElabs, a Division of Atico International USA, INC.

Tolnaftate

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Keep out of reach of children

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

Directions

Other information

store between 2o and 30oC (36o and 86oF)

Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purfied water, sorbitan monostearate, stearyl alcohol

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30PM.

Image of Tolnaftate Cream Carton Label

Image of Tolnaftate Cream Tube Label

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-102
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
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Mineral Oil (UNII: T5L8T28FGP)  
Methylparaben (UNII: A2I8C7HI9T)  
Ceteth-20 (UNII: I835H2IHHX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
Sorbitan Monostearate (UNII: NVZ4I0H58X)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51852-102-011 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/01/2010
Labeler - LIFElabs, a Division of Atico International, USA, INC. (073876450)

Revised: 8/2010
Document Id: e199cc9f-e38c-43e9-a515-f868abcf931b
Set id: 4705fac4-f797-48fd-b0c4-79c7e3b8a04a
Version: 5
Effective Time: 20100823
 
LIFElabs, a Division of Atico International, USA, INC.