TOLNAFTATE ANTIFUNGAL- tolnaftate cream 
Taro Pharmaceuticals U.S.A., 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 1%

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

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.

Directions

Other information

Inactive ingredients

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

Questions?

Call 1-866-923-4914

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Cures & Prevents Most Athlete's Foot

Antifungal Cream

Tolnaftate Cream 1%

Antifungal

NET WT 1 oz (30 g)

Principal Display Panel - 30 g Tube Carton
TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2020
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)  
Product Characteristics
ColorWHITE (opaque, white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2020-11 in 1 CARTON01/01/1995
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-2020-21 in 1 CARTON01/01/1995
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C01/01/1995
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2020)

Revised: 1/2020
Document Id: 15beaada-5700-46cd-97bc-9da26393c181
Set id: fa16fa08-fbbd-4f45-b64a-9bffe78e8861
Version: 3
Effective Time: 20200131
 
Taro Pharmaceuticals U.S.A., Inc.