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.

----------

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 Type HUMAN OTC DRUG Item Code (Source) NDC:24385-032
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
titanium dioxide (UNII: 15FIX9V2JP)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24385-032-03 1 in 1 CARTON
1 30 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333C 02/17/2006
Labeler - Amerisource Bergen (007914906)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(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