HAN-I-FOAM (ALCOHOL) LIQUID [MOMAR INCORPORATED]

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HAN-I-FOAM (ALCOHOL) LIQUID [MOMAR INCORPORATED]
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NDC 63533-855-08, 63533-855-10, 63533-855-11, 63533-855-12, 63533-855-17, 63533-855-18
Set ID 5045c8ff-7591-47b0-b219-aba27a6fe039
Category HUMAN OTC DRUG LABEL
Packager Momar Incorporated
Generic Name
Product Class
Product Number
Application Number PART333E
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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, PEG-10 acrylate, perfluorohexylethyl acrylate copolymer, propylene glycol, fragrance

  • Han-I-Foam 6585

    product label

    product label

    Han-I-Foam 6585

  • INGREDIENTS AND APPEARANCE
    HAN-I-FOAM  
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63533-855
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63533-855-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2020
    2NDC:63533-855-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2020
    3NDC:63533-855-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2020
    4NDC:63533-855-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product08/10/2020
    5NDC:63533-855-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2020
    6NDC:63533-855-121000 mL in 1 BAG; Type 0: Not a Combination Product08/10/2020
    7NDC:63533-855-081 in 1 BOX08/10/2020
    71000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/10/2020
    Labeler - Momar Incorporated (003266616)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(63533-855)
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