PREMIER VALUE TOLNAFTATE ANTIFUNGAL - tolnaftate cream 
CHAIN DRUG CONSORTIUM, 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                                                                              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 alchol, cetyl alcohol, sorbitan monstearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben.

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

3301 N.W. BOCA RATON BLVD., SUITE 101

BOCA RATON, FL 33431

MADE IN KOREA

image of carton labelEnter section text here

PREMIER VALUE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-014
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:68016-014-791 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/20/2012
Labeler - CHAIN DRUG CONSORTIUM, LLC (101668460)

Revised: 1/2012
Document Id: 4eedcf7f-412d-4d50-b50e-48b9fd4c6a1c
Set id: 383d481c-2354-4605-946e-be71f27c4fd4
Version: 1
Effective Time: 20120120
 
CHAIN DRUG CONSORTIUM, LLC