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Tinactin by Bayer HealthCare LLC.

Dosage form: cream
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: Bayer HealthCare LLC.
NDC Code: 11523-0934

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.

Tinactin ®

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses
  • cures most jock itch (tinea cruris)
  • for effective relief of itching, chafing and burning

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 2 weeks

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

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 thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 2 weeks; if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

Questions?

1-866-360-3266

Distributed by Bayer Healthcare LLC, Whippany, NJ, USA, 07981.

PRINCIPAL DISPLAY PANEL - 15g Tube Carton

Tinactin®



tolnaftate



ANTIFUNGAL

CREAM

Relieves:

  • itching
  • burning
  • chafing

NET WT



15g (1/2 oz)

TINACTIN 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0934
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 
CETOSTEARYL ALCOHOL 
CHLOROCRESOL 
MINERAL OIL 
PROPYLENE GLYCOL 
WATER 
SODIUM PHOSPHATE, MONOBASIC 
PETROLATUM 
Product Characteristics
Colorwhite (White to Off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-0934-21 TUBE in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/23/1993
Labeler - Bayer HealthCare LLC. (112117283)

 
Bayer HealthCare LLC.

Medically reviewed on Aug 14, 2017

See Also

Further information

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

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