TOLNAFTATE- tolnaftate cream 
Discount Drug Mart, 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.

----------

Discount Drug Mart Tolnaftate Antifungal Cream

Active Ingredients

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

When using this product

avoid contact with the 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

Carbomer, Cetyl alcohol, Chlorocresol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

Principal Display Panel

Tolnaftate

tolnaftate.carton

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-994
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PARAFFIN (UNII: I9O0E3H2ZE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
CHLOROCRESOL (UNII: 36W53O7109)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-994-011 in 1 BOX11/09/2015
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/09/2015
Labeler - Discount Drug Mart, Inc. (047741335)

Revised: 12/2020
Document Id: b7b83259-3dd5-947c-e053-2995a90a2c32
Set id: 2420a06e-11f9-4de1-e054-00144ff88e88
Version: 5
Effective Time: 20201230
 
Discount Drug Mart, Inc.