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Tolnaftate by Major Pharmaceuticals

Dosage form: cream
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: Major Pharmaceuticals
NDC Code: 0904-0722

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.

Drug Facts

Active ingredient

Tolnaftate USP 1%

Purpose

Antifungal

Uses
  • for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • for effective relief of itchy, scaly skin between the toes
  • clears up most athlete's foot infection and with daily use helps keep it from coming back

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 eyes

Stop use and ask a doctor if
  • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
  • irritation occurs or if there is no improvement within 2 weeks (for jock itch)

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions
  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product

For athlete's foot

  • use daily for 4 weeks. If condition persists longer, consult a doctor
  • pay special attention to the spaces between the toes
  • wear well fitting ventilated shoes
  • change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

Other information
  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • Lot No. and Exp date: see crimp on tube or see box

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Phosphate Monobasic, White Petrolatum

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

Principal Display Panel – 0.5 oz Tube

MAJOR® *Compare to Active Ingredient of Tinactin®

NDC 0904-0722-36

Antifungal

Cream (Tolnaftate 1%) N309040722362

CURES ATHLETE'S FOOT, *This product is not manufactured or

JOCK ITCH AND RINGWORM distributed by Schering-Plough Healthcare

Relives Burning and Itching Products, Inc. owner of the registered

Odorless Greaseless Non-Staining trademark, Tinactin®

Net Wt. 0.5 OZ (14.18 g)

Principal Display Panel – 0.5 oz Carton

MAJOR® NDC 0904-0722-36

Antifungal *Compare to Active Ingredient of Tinactin®

Cream

(Tolnaftate 1%) Net Wt. 0.5 OZ (14.18 g)

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0722
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETOSTEARYL ALCOHOL 
CETETH-20 
CHLOROCRESOL 
MINERAL OIL 
PETROLATUM 
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:0904-0722-361 TUBE in 1 CARTON
114.18 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/11/2010
Labeler - Major Pharmaceuticals (191427277)
Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(0904-0722)

 
Major Pharmaceuticals

← See all Tolnaftate brands

Medically reviewed on Jul 3, 2018

Further information

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

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