Label: TINACTIN- tolnaftate cream

  • NDC Code(s): 11523-1190-1, 11523-1190-2
  • Packager: Bayer HealthCare LLC.
  • 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 September 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief of itching, burning and cracking
  • Warnings

    For external use only

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

    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

    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
    • 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 persists 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 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 - 15 g Tube Carton

    Tinactin AF Cream 15g Carton

    TOUCH ACTIN'

    Tinactin ®

    tolnaftate ANTIFUNGAL

    CURES AND PREVENTS

    MOST ATHLETE'S FOOT

    Relieves:

    • itching
    • burning

    CREAM

    NET WT 15G (1/2 OZ)

  • INGREDIENTS AND APPEARANCE
    TINACTIN 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1190
    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:11523-1190-11 in 1 CARTON12/12/2002
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11523-1190-21 in 1 CARTON12/12/2002
    230 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)
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