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Winco Foods Tolnaftate

Medically reviewed on May 11, 2017

Dosage form: cream
Ingredients: tolnaftate 10mg in 1g
Labeler: Winco Foods, LLC
NDC Code: 67091-276

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.

Active ingredient (in each gram)  Purpose

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

Uses

  • Proven clinically effective in the treatment of athlete's foot (tinea pedis) and rignworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning and cracking

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

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children

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

Directions

  • wash affected area and dry thoroguhly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Other information

  • store between 20° to 25C° (68° to 77F°)
  • Lot No & Exp. Date: see box or see crimp of tube

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

WINCO FOODS TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-276
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
tolnaftate (tolnaftate) tolnaftate10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 
CETYL ALCOHOL 
METHYLPARABEN 
MINERAL OIL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:67091-276-281 TUBE in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/06/2015
Labeler - Winco Foods, LLC (056098817)

 
Winco Foods, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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