Label: LOTRIMIN DAILY PREVENTION- tolnaftate powder

  • NDC Code(s): 11523-0011-1, 11523-0011-2
  • 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 November 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Tolnaftate 1%

  • PURPOSE

    Purpose

    Antifungal

  • Use

    Use

    • clinically proven to prevent most athlete' s foot with daily use

  • WARNINGS

    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 the eyes

    Stop use and ask a doctor if irritation occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions

    • to prevent athlete's foot, wash the feet and dry thoroughly.

    • apply a thin layer of the product on the feet once or twice daily (morning and/or night).

    • supervise children in the use of this product.

    • pay special attention to spaces between the toes; wear well-fitting ventilated shoes and socks at least

    once daily.

  • Other information

    Other information

    store between 20º to 25ºC (68º– 77ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzethonium chloride;corn starch, kaolin;sodium bicarbonate

  • Questions

    Questions? 1-866-360-3266

  • Package Display 3 oz. label

    LOTRIMIN® AF

    TOLNAFTATE ANTIFUNGAL

    medicated foot powder

    DAILY

    PREVENTION

    clinically proven to

    prevent most

    athlete's foot

    • stops the growth of most athlete's foot fungus
    • absorbs sweat & keeps feet dry
    • destroys odor

    NET WT 90g (3 OZ)

    Front label 3 oz.

    Back label

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN DAILY PREVENTION 
    tolnaftate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0011
    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
    KAOLIN (UNII: 24H4NWX5CO)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0011-190 g in 1 BOTTLE; Type 0: Not a Combination Product02/14/2020
    2NDC:11523-0011-228 g in 1 BOTTLE; Type 0: Not a Combination Product11/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/14/2020
    Labeler - Bayer HealthCare LLC. (112117283)
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