Your browser does not support JavaScript! ANTIFUNGAL (TOLNAFTATE) CREAM [RITE AID CORPORATION]
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ANTIFUNGAL (tolnaftate) cream
[Rite Aid Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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, monoamylamine, PEG-400, propylene glycol, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Tinactin® Antifungal Cream

foot care

antifungal cream

relieves itching & burning

tolnaftate 1%

cures and prevents most athlete’s foot

Antifungal Cream Carton Image 1
Antifungal Cream Carton Image 2
ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-0701
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
TITANIUM DIOXIDE 
PENTYLAMINE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0701-11 in 1 CARTON
114 g in 1 TUBE
2NDC:11822-0701-21 in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/23/2005
Labeler - Rite Aid Corporation (014578892)

Revised: 1/2013
 
Rite Aid Corporation

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