Label: ACTION INSTANT HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 18, 2020

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  • Drug Facts

  • Active Ingredient:

    Alcohol Denat 75%

    Purpose

    Antimicrobial

  • Uses:

    • Hand sanitizer helps to reduce bacteria on the skin that could cause disease
    • Recommended for repeated use
  • WARNINGS:

    FOR EXTERNAL USE ONLY

    • Flammable. Keep away from fire or flame.

    When using this product

    • do not use in or near eyes. 
    • In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash appears and lasts

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Direction Of Use:

    Squeeze amount in your palm then briskly rub hands together until dry.

    Children under 3 years of age should be supervised when using this product

  • Other Information:

    Store below 110F (43C)

  • Inactive Ingredients:

    Aqua, Glycerin, Acrylates/C10-30 Alkyl Acrylate Cross-polymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Panthenol, Tocopheryl Acetate, Fragrance.

  • Questions or comments?

    Call Customer Care Line 1300 88 4848

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ACTION INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80613-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80613-000-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2019
    Labeler - MAESTRO LABORATORIES SDN. BHD. (596768965)
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