Your browser does not support JavaScript! ANTIFUNGAL (TOLNAFTATE) SOLUTION [PERRIGO NEW YORK INC]
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ANTIFUNGAL (tolnaftate) solution
[Perrigo New York Inc]


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

for effective treatment of most:
athlete’s foot (tinea pedis)
ringworm (tinea corporis)
jock itch (tinea cruris)
for effective relief of itchy, scaly skin between the toes
helps prevent most athlete’s foot from coming back with daily use

Warnings

For external use only.

Do not use

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

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

irritation occurs
athlete’s foot or ringworm does not improve within 4 weeks
jock itch does not improve within 2 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean the affected area and dry thoroughly
apply a thin layer of the product over affected area twice daily (morning and night)
supervise children in the use of this product

For athlete’s foot

use daily for 4 weeks
pay special attention to the spaces between the toes
wear well-fitting, ventilated shoes
change shoes and socks at least once daily
to prevent athlete’s foot, clean and dry feet thoroughly. Apply as above once or twice daily.

For ringworm

use daily for 4 weeks. If condition lasts longer, ask a doctor

For jock itch

use daily for 2 weeks. If condition lasts longer, ask a doctor
this product is not effective on the scalp or nails

Inactive ingredients

butylated hydroxytoluene, polyethylene glycol

Questions or comments?

1-800-719-9260

Principal Display Panel

Tolnaftate 1% Topical Solution

Antifungal

For the cure of most athlete’s foot, jock itch and ringworm

NET 1/3 FL OZ (10 mL)

Perrigo Antifungal
ANTIFUNGAL 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45802-701
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
POLYETHYLENE GLYCOLS 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-701-111 in 1 CARTON
110 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/17/2011
Labeler - Perrigo New York Inc (078846912)

Revised: 11/2013
 
Perrigo New York Inc

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