Label: SANITIZER liquid

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

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Drug Label Information

Updated December 23, 2020

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  • Active Ingredient(s)

    Hexamine:0.23%-0.27%

    Benzalkonium bromide:0.12%-0.14%

  • Purpose

    Antiseptic

  • Use

    To decrease bacteria on the skin that could cause disease

    recommended for repeat use

    Use without water

  • Warnings

    For external use only.

    Keep out of reach of children, in case of accidental ingestion,seek professional assistance.

    Discontinue if skin becomes irritated and ask a doctor

    Do not use it together with peroxide and detergent

    Keep in a cool and dry place

  • Do not use

    it together with peroxide and detergent

  • WHEN USING

    .

  • STOP USE

    discontinue if skin becomes irritated and ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.in case if accidental ingestion,seek professional assistance

  • Directions

    Wet hands throughly with product and rub until dry without wiping

    For children under 6 years old,use only under adult supervision

  • Inactive ingredients

    water

  • Package Label - Principal Display Panel

    package label

  • INGREDIENTS AND APPEARANCE
    SANITIZER 
    sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:93068-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM0.1 g  in 100 mL
    METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE0.27 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:93068-003-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/22/2020
    Labeler - KANGSHENG MEDICAL TECHNOLOGY (WENZHOU) CO. , LTD (554543825)
    Establishment
    NameAddressID/FEIBusiness Operations
    KANGSHENG MEDICAL TECHNOLOGY (WENZHOU) CO. , LTD554543825manufacture(93068-003)
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