RECENS FOAM (ALCOHOL) LIQUID [CERTUS MEDICAL, INC.]

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RECENS FOAM (ALCOHOL) LIQUID [CERTUS MEDICAL, INC.]
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NDC 75990-792-07, 75990-792-12, 75990-792-13
Set ID 4becfd5c-c64f-4926-b835-71bdfdfd55dd
Category HUMAN OTC DRUG LABEL
Packager Certus Medical, Inc.
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

    ffor 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

     apply to hands and rub lightly until dry without wiping or rinsing

  • Drug Facts Box OTC-Inactive Ingredient Section

    water, PEG-10 acrylate, perfluorohexylethyl acrylate copolymer, propylene glycol

  • Recens Foam 6792

    product label

    Recens Foam  6792

  • INGREDIENTS AND APPEARANCE
    RECENS FOAM 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-6792
    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:75990-6792-7700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
    2NDC:75990-6792-11000 mL in 1 BAG; Type 0: Not a Combination Product07/08/2019
    3NDC:75990-6792-3800 mL in 1 BAG; Type 0: Not a Combination Product07/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/08/2019
    Labeler - Certus Medical, Inc. (966433653)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(75990-6792)
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