Label: TINACTIN- tolnaftate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated August 14, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 15g Tube Carton

    Carton

    Tinactin®



    tolnaftate



    ANTIFUNGAL

    CREAM

    Relieves:

    • itching
    • burning
    • chafing

    NET WT



    15g (1/2 oz)

  • INGREDIENTS AND APPEARANCE
    TINACTIN 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0934
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Colorwhite (White to Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0934-21 in 1 CARTON12/12/2002
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/23/1993
    Labeler - Bayer HealthCare LLC. (112117283)