QS PLUS INSTANT HAND SANITIZER (BENZETHONIUM CHLORIDE) LIQUID [ROMAINE COMPANIES]

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QS PLUS INSTANT HAND SANITIZER (BENZETHONIUM CHLORIDE) LIQUID [ROMAINE COMPANIES]
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NDC 13302-575-10, 13302-575-12, 13302-575-13, 13302-575-16, 13302-575-17, 13302-575-18, 13302-575-27
Set ID 1926d013-2d8e-4d54-990a-317906fbe5ec
Category HUMAN OTC DRUG LABEL
Packager Romaine Companies
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts Box OTC-Active Ingredient Section

    benzethonium chloride USP 0.2%

  • Drug Facts Box OTC-Indications & Usage Section

    For hand-washing to decrease bacteria on the skin, only when water is not available

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box-OTC When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box-OTC Stop Use Section

    irritation and redness develop

  • Drug Facts Box-OTC Keep Out Of Reach Of Children Section

    If swallowed, get medical help or contact a Poison Control Center right away

  • Drug Facts Box-OTC Dosage & Administration Section

    press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

    rub hands together until dry

    wash hands with soap and water at earliest opportunity

  • Drug Facts Box-OTC Inactive Ingredient Section

    water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, fragrance

  • QS Plus Instant Hand Sanitizer

    product label

    QS Plus Instant Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    QS PLUS INSTANT HAND SANITIZER 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13302-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13302-575-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product10/24/2018
    2NDC:13302-575-121000 mL in 1 BAG; Type 0: Not a Combination Product10/24/2018
    3NDC:13302-575-13800 mL in 1 BAG; Type 0: Not a Combination Product10/24/2018
    4NDC:13302-575-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/24/2018
    5NDC:13302-575-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product10/24/2018
    6NDC:13302-575-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/24/2018
    7NDC:13302-575-16236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/24/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/24/2018
    Labeler - Romaine Companies (929229797)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(13302-575)
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