TOLNAFTATE ANTIFUNGAL- tolnaftate cream 
Central Texas Community Health Centers

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

HOW SUPPLIED

Product: 76413-321

NDC: 76413-321-15 15 g in a TUBE

TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM

Label Image
TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-321(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:76413-321-1515 g in 1 TUBE; Type 0: Not a Combination Product01/01/1995
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C01/01/1995
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Travis County Healthcare District797039398RELABEL(76413-321) , REPACK(76413-321)

Revised: 5/2018
Document Id: 84b31d3c-7651-40d6-a11b-d21756fcb85e
Set id: 2b2303dd-fec2-4ff4-a0ae-6bfb921dd246
Version: 2
Effective Time: 20180501
 
Central Texas Community Health Centers