Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 74201-016-02
  • Packager: Jiangsu Intco Medical Products Co Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 6, 2023

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  • Active Ingredient

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    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 or flame

  • Do not use

    in children less than 2 months of age. on open skin wounds

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact, 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

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using products.
  • Other information

    • Store below 110°F(43C°)
    • Avoid freezing and excessive heat above 40C (104F)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Aloe Vera, Carbomer Interpolymer (type B), Glycerin, Lemon oil, Triethanolamine, Water (Aqua)

  • Package Label - Principal Display Panel

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74201-016
    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
    LEMON OIL (UNII: I9GRO824LL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74201-016-02473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/08/2020
    Labeler - Jiangsu Intco Medical Products Co Ltd (529128686)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Intco Medical Products Co Ltd529128686manufacture(74201-016)
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