Label: LOTRIMIN DAILY PREVENTION DEO- tolnaftate aerosol, powder

  • NDC Code(s): 11523-0010-1, 11523-0010-2
  • 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 July 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    (To Deliver)Tolnaftate 1%

  • PURPOSE

    Purpose

    Antifungal

  • Use

    Use

    clinically proven to prevent most athlete’s foot with daily use

  • WARNINGS

    Warnings

    For external use only

    Flammable: Do not use near heat, flame, or while smoking

    Do not use on children under 2 years of age unless directed by a doctor

    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.

    When using this product

    avoid contact with the eyes
    use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
    do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF

  • Directions

    Directions

    to prevent athlete’s foot, wash the feet and dry thoroughly.
    shake can well and spray 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 change shoes and socks at least once daily.

  • Other information

    Other Information

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    butylated hydroxytoluene, fragrance, isobutane, PEG-12-Buteth-16, SD alcohol 40B (10.5% v/v), talc

  • QUESTIONS

    Questions? 1-866-360-3266

  • Display can 160 grams

    Lotrimin®AF

    TOLNAFTATE ANTIFUNGAL

    deodorant powder spray

    DAILY PREVENTION

    clinically proven to

    prevent most

    athlete's foot

    • stops the growth of most athlete's foot fungus
    • instantly cools and dries feet
    • fights odor all day

    NET WT 160 g (5.6 OZ)

    Can label

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN DAILY PREVENTION DEO 
    tolnaftate aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0010
    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
    ALCOHOL (UNII: 3K9958V90M)  
    TALC (UNII: 7SEV7J4R1U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    ISOBUTANE (UNII: BXR49TP611)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0010-1160 g in 1 CAN; Type 0: Not a Combination Product02/14/2020
    2NDC:11523-0010-2133 g in 1 CAN; Type 0: Not a Combination Product02/14/2020
    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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