Label: SANITIZER liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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)