Label: 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 February 19, 2021

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce germs on the skin.

  • Warnings

    • For external use only.
    • Flammable: Keep away from heat or flame.
  • Do not use

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

    When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop using and ask a doctor if irritation or redness develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

  • Directions

    • Squeeze a significant amount in your palm and rub hands until fully dry.
    • Rinse free.
  • Other information

    • Store below 110 °F（43° C).
  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe Barbadensis leaf Juice, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water.

  • Package Label - Principal Display Panel

    1000 mL NDC: 42509-036-01 1000ml label1000ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42509-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42509-036-011000 mL in 1 BAG; Type 0: Not a Combination Product02/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/19/2021
    Labeler - WESSCO International (118553619)
    Establishment
    NameAddressID/FEIBusiness Operations
    WESSCO International118553619label(42509-036)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang iColor Biotech Co., Ltd554528308manufacture(42509-036)
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