WINCO FOODS TOLNAFTATE- tolnaftate cream 
Winco Foods, LLC

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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Winco Antifungal Tolnaftate 1% Cream 1 oz (24193, 2018)

Active ingredient (in each gram)  Purpose

Tolnaftate 1%--------------------------------------------------------------------------------- Antifungal

Uses

Warnings:

For external use only

Do not use on children under 2 years of age unless directed by a doctor

When using this product

Avoid contact with the eyes.

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

buylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN KOREA

24193

WINCO FOODS TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-276
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 (UNII: I835H2IHHX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-276-281 in 1 BOX05/11/2017
128 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/06/2015
Labeler - Winco Foods, LLC (056098817)

Revised: 8/2023
Document Id: 04033026-7066-e651-e063-6294a90a6c70
Set id: 218f7613-1401-4f1b-bf46-576b536825af
Version: 6
Effective Time: 20230828
 
Winco Foods, LLC