Label: PANODYNE HAND SANITIZER 99.9% PROTECTION- hand sanitizer gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 7, 2020

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  • Active Ingredient(s)

    Ethanol 65%

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    May producean allergic reaction. Flammable. For external use only. Keep away from heat, sparks, open flame, hot surfaces. Cause serious eye irritation. Keep out of reach of children. No smoking.

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store at room temperature, out of direct sunlight
  • Inactive ingredients

    Water, Glycerine, Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Cucumis satuivuc (Cucumber) oil.

  • Package Label - Principal Display Panel

    500

  • INGREDIENTS AND APPEARANCE
    PANODYNE HAND SANITIZER 99.9% PROTECTION 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73968-1018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK) 2.5 mL  in 500 mL
    WATER (UNII: 059QF0KO0R) 130 mL  in 500 mL
    GLYCERIN (UNII: PDC6A3C0OX) 15 mL  in 500 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 2.5 mL  in 500 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73968-1018-1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/07/2020
    Labeler - Multibrands International Limited (236858853)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Multibrands International Limited236858853label(73968-1018) , manufacture(73968-1018)
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