DG ATHLETES FOOT - tolnaftate cream 
TAI GUK PHARM. CO., LTD.

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                                                                   Purpose

Tolnaftate 1% ......................................................................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

Lot No. and Exp. Date: see box or see crimp of the tube.  Store between 20o to 25oC (68o to 77oF)

Inactive ingredients

propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben.

Distributed By Dolgencorp, LLC

100 Mission Ridge

Goodlettsville, TN 37072

image of carton labelEnter section text here

DG ATHLETES FOOT 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-3050
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68169-3050-21 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/10/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
TAI GUK PHARM. CO., LTD.631101656manufacture(68169-3050)

Revised: 12/2010
Document Id: 87aecaaf-36ab-452c-bf89-cb5e3ac3a4c2
Set id: 51a9f174-08bf-4202-956c-cb56823c6c41
Version: 3
Effective Time: 20101210
 
TAI GUK PHARM. CO., LTD.