TOLNAFTATE- tolnaftate powder 
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 1% Antifungal Powder Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

Warnings

For external use only

Do not use

on children under 2 years of age except under the advice and supervision of a doctor

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

Keep out of reach of children.

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

Directions

wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
supervise children in the use of this product
for athlete’s foot: pay special attention to the 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 persists 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 between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, talc

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tinactin® active ingredient

Antifungal Powder

Tolnaftate 1%

Cures & Prevents Most Athlete’s Foot

Relieves Itching & Burning

Tolnaftate 1% Antifungal Powder Label

Tolnaftate 1% Antifungal Powder Label

Tolnaftate 1% Antifungal Powder Label

TOLNAFTATE 
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-034
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
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-034-8645 g in 1 BOTTLE; Type 0: Not a Combination Product12/07/200512/07/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/07/200512/07/2010
Labeler - Perrigo New York Inc (078846912)

Revised: 10/2017
 
Perrigo New York Inc