TOLNAFTATE  ANTIFUNGAL- tolnaftate cream 
Amerisource Bergen

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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Tolnaftate 1% Cream
Antifungal Cream

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Ask a doctor before use

  • on children under 2 years of age

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

For athlete's foot

pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

Other information

Inactive ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Questions?

Call 1-866-923-4914

Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

GOOD
NEIGHBOR
PHARMACY®

Compare to the Tinactin® active ingredient*

NDC 24385-032-03

Tolnaftate 1% Cream
Antifungal Cream

Cures & Prevents Most Athlete's Foot

NET WT 1 oz (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
TOLNAFTATE  ANTIFUNGAL
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24385-032
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (Tolnaftate) Tolnaftate10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
POLYETHYLENE GLYCOL 400 
titanium dioxide 
petrolatum 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-032-031 in 1 CARTON
130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C02/17/2006
Labeler - Amerisource Bergen (007914906)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(24385-032)

Revised: 1/2013
Document Id: bd8164cd-c58f-4f72-99a2-5fdb797521a7
Set id: a3c9b783-4a36-46b3-a0dc-0696907eaebb
Version: 2
Effective Time: 20130115
 
Amerisource Bergen