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Tolnaftate by A-S Medication Solutions

Dosage form: cream
Ingredients: TOLNAFTATE 1g in 100g
Labeler: A-S Medication Solutions
NDC Code: 50090-0161

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.

Perrigo Tolnaftate Cream USP, 1% Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses
  • proven clinically effective in the treatment of most
  • athlete’s foot (tinea pedis)
  • ringworm (tinea corporis)
  • helps prevent most athlete’s foot with daily use
  • for effective relief of
  • itching
  • burning
  • cracking

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 unless directed by a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
  • wash affected area and dry thoroughly
  • 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 lasts 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 at 68°-77°F (20°-25°C)

Inactive ingredients

butylated hydroxytoluene, carbomer homopolymer type C, monoamylamine, PEG-400, propylene glycol, titanium dioxide

Questions or comments?

1-800-719-9260

Tolnaftate
TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0161(NDC:45802-032)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
TITANIUM DIOXIDE 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50090-0161-01 TUBE in 1 CARTON
1 14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/02/2011
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-0161)

 
A-S Medication Solutions

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Medically reviewed on Sep 7, 2017

Further information

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

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