TOLNAFTATE- tolnaftate cream 
Perrigo New York 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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Perrigo Tolnaftate Cream USP, 1% Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most
athlete’s foot (tinea pedis)
ringworm (tinea corporis)
helps prevent most athlete’s foot with daily use
for effective relief of
itching
burning
cracking

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks

Do not use

on children under 2 years of age unless directed by a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night)
supervise children in the use of this product
for athlete’s foot: pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
use daily for 4 weeks. If condition lasts longer, ask a doctor.
to prevent athlete’s foot, apply once or twice daily (morning and/or night)
this product is not effective on the scalp or nails

Other information

store at 68°-77°F (20°-25°C)

Inactive ingredients

butylated hydroxytoluene, carbomer homopolymer type C, monoamylamine, PEG-400, propylene glycol, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Cures Most Athlete’s Foot

Relieves Itching & Burning

Compare to Tinactin® active ingredient

Tolnaftate Cream USP, 1%

Antifungal

Tolnaftate Cream USP, 1% Carton Image 1

Tolnaftate Cream USP, 1% Carton Image 1

Tolnaftate Cream USP, 1% Carton Image 2

Tolnaftate Cream USP, 1% Carton Image 1

Tolnaftate Cream USP, 1% Carton Image 2

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-032-011 in 1 CARTON08/02/201111/09/2015
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:45802-032-031 in 1 CARTON08/02/201111/09/2015
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/02/201111/09/2015
Labeler - Perrigo New York Inc (078846912)

Revised: 11/2017
 
Perrigo New York Inc