Label: HAN-I-FOAM- alcohol liquid

  • NDC Code(s): 63533-855-08, 63533-855-10, 63533-855-11, 63533-855-12, view more
    63533-855-14, 63533-855-17, 63533-855-18
  • Packager: Momar Incorporated
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 10, 2020

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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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