SANI-SPRITZ (ALCOHOL) LIQUID [ABC COMPOUNDING CO., INC.]

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SANI-SPRITZ (ALCOHOL) LIQUID [ABC COMPOUNDING CO., INC.]
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NDC 62257-738-14, 62257-738-15, 62257-738-16, 62257-738-17, 62257-738-18, 62257-738-24, 62257-738-55
Set ID ac88c676-c396-4fb8-9e5c-77c726ed69d8
Category HUMAN OTC DRUG LABEL
Packager ABC Compounding Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART333
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  • Drug Facts Box OTC-Active Ingredient Section

    Ethyl Alcohol 62%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • 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

    FLAMMABLE, keep away from fire and flames

    For external use only

  • 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 and allow to dry without wiping

  • Drug Facts Box OTC-Inactive Ingredient Section

    water, propylene glycol, acid blue 25

  • Sani-Spritz

    product label

    Sani-Spirtz Label

  • INGREDIENTS AND APPEARANCE
    SANI-SPRITZ 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-738
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62257-738-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
    2NDC:62257-738-15946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
    3NDC:62257-738-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
    4NDC:62257-738-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/31/2009
    Labeler - ABC Compounding Co., Inc. (003284353)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(62257-738)
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