Perrigo Tolnaftate Cream USP, 1% Drug Facts

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOLNAFTATE- tolnaftate cream 
A-S Medication Solutions

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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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

HOW SUPPLIED

Product: 50090-0161

Tolnaftate

Label Image
TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-0161(NDC: 45802-032)
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-0161-01 in 1 CARTON11/28/201410/31/2017
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/02/201110/31/2017
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0161)

Revised: 1/2020
Document Id: e41ede8c-535d-42f8-bf79-0fe0c1abad44
Set id: c86572bf-1541-40bf-b168-7291954144ee
Version: 6
Effective Time: 20200117
 
A-S Medication Solutions