TOLNAFTATE- tolnaftate cream 
Taro Pharmaceuticals, 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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TOLNAFTATE Antifungal Cream

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only.

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

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

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)

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

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product 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 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

Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015-4616

100% Satisfaction Guaranteed
www.walgreens.com

Made in Canada.

PRINCIPAL DISPLAY PANEL - 30 g Label

Walgreens

NDC 03630-020-02

TOLNAFTATE Antifungal Cream

Tolnaftate Cream, 1%
NET WT 1 OZ (30 g)

Principal Display Panel - 30 g Label
TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61360-2020
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
titanium dioxide (UNII: 15FIX9V2JP)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61360-2020-21 in 1 CARTON
130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33308/20/2009
Labeler - Taro Pharmaceuticals, Inc. (206263295)

Revised: 12/2009
Document Id: 15ae5419-e1b9-4192-a427-358f1c57d31f
Set id: bda6e4e1-80d1-4490-97fc-a11ef70add21
Version: 1
Effective Time: 20091204
 
Taro Pharmaceuticals, Inc.