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Tolnaftate by Faria Limited dba Sheffield Pharmaceuticals

Medically reviewed on Jun 11, 2018

Dosage form: cream
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: Faria Limited dba Sheffield Pharmaceuticals
NDC Code: 11527-051

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 Cream

Uses
  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • Relieves the  itching, irratation, redness, scaling and discomfort which can accompany these conditions.

Warnings
  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only avoid contact with eyes.
  • 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

  • Pay special attention to the spaces between the toes.
  • Wear well fitting ventilated shoes.
  • Change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • 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).
  • Close cap tighty after ever use.

Inactive ingredients

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

Questions?

1-800-222-1087

Principal Display Panel – 1.25 oz Tube

Dr. Sheffield's NDC 11527-051-40

Antifungal Cream (Tolnaftate 1%) Made in the USA

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM                                 Net Wt. 1.25 OZ (35.4 g)

Principal Display Panel – 1.25 oz Carton

Dr. Sheffield's NDC 11527-051-40

Antifungal Cream (Tolnaftate 1%) Made in the USA

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM                                               Net Wt. 1.25 OZ (35.4 g)

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-051
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:11527-051-401 TUBE in 1 CARTON
135.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/07/2009
Labeler - Faria Limited dba Sheffield Pharmaceuticals (151177797)
Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(11527-051)

 
Faria Limited dba Sheffield Pharmaceuticals

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Further information

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

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