Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 43493-0000-0, 43493-0000-1, 43493-0000-2, 43493-0000-3
  • Packager: Avaria Health & Beauty Corp
  • 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 December 21, 2022

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  • Active Ingredient(s)

    Ethyl Alcohol 70%. Purpose: Antiseptic

  • 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

    For external use only

    Flammable. Keep away from heat and flame.

  • Do not use

    • In children less than 2 months of age.
    • On open skin wounds.
  • When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • 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 between 15 - 40C (59 - 86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Carbomer, Hyaluronic Acid, Aminomethyl Propanol ,Isopropyl Myristate

  • Questions or comments?

    Call toll-free 1.888.829.7165

  • Package Label - Principal Display Panel

    13.5 fl oz (400 ml)

    NDC 43493-0000-0

    front panel

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL280 mL  in 400 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43493-0000-0400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    2NDC:43493-0000-1250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    3NDC:43493-0000-260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    4NDC:43493-0000-31000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Avaria Health & Beauty Corp (251366043)
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