TOLNAFTATE- tolnaftate cream 
Valu Merchandisers, Co.

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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Best Choice Tolnaftate 1% Cream

Active ingredient (in each gram)

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

Inactive ingredients

cetyl alcohol, ethylparaben, glycerin, glyceryl stearate, mineral oil, petrolatum, polysorbate 80, purified water, sodium lauryl sulfate

Other information

Package label

Best Choice Tolnaftate 1%

carton

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-354
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
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLPARABEN (UNII: 14255EXE39)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-354-011 in 1 BOX03/02/2012
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2012
Labeler - Valu Merchandisers, Co. (868703513)

Revised: 2/2023
Document Id: f43630ef-eb28-076f-e053-2995a90a79ed
Set id: 0fa1e8b6-18d8-4427-99c1-d8130e0cf133
Version: 6
Effective Time: 20230208
 
Valu Merchandisers, Co.