CVS ATHLETES FOOT TOLNAFTATE- tolnaftate cream 
CVS PHARMACY

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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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

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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

www.cvs.com

Made in Korea

image of carton label

CVS ATHLETES FOOT TOLNAFTATE 
tolnaftate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-522
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-522-28 1 in 1 CARTON
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 10/10/2014
Labeler - CVS PHARMACY (062312574)

Revised: 10/2014
Document Id: 4b66f3c0-3cc3-40c3-a146-0f24b1853dc4
Set id: e71943e9-dc2a-41ab-bffb-153ce645730a
Version: 2
Effective Time: 20141010
 
CVS PHARMACY