RECENS (ALCOHOL) GEL [CERTUS MEDICAL, INC.]

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RECENS (ALCOHOL) GEL [CERTUS MEDICAL, INC.]
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NDC 75990-605-01, 75990-605-03, 75990-605-05, 75990-605-07, 75990-605-08, 75990-605-09, 75990-605-10, 75990-605-11, 75990-605-12, 75990-605-13, 75990-605-14, 75990-605-15, 75990-605-24, 75990-605-27, 75990-605-28
Set ID 839487e4-a036-4b00-8f42-4890e4165526
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

    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

    wet hands thoroughly with product and allow to dry without wiping

  • Drug Facts Box OTC-Inactive Ingredient Section

    water, diisopropylamine, carbomer, propylene glycol, DMDM hydantoin, tocopheryl acetate, aloe barbadensis

  • Recens Gel 6966 1000ml

    product labelproduct label

    Recens Gel 1000ml product label

  • INGREDIENTS AND APPEARANCE
    RECENS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-605
    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)  
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75990-605-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    2NDC:75990-605-011200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product06/25/2020
    3NDC:75990-605-03350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product06/25/2020
    4NDC:75990-605-05540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    5NDC:75990-605-07700 mL in 1 BAG; Type 0: Not a Combination Product06/25/2020
    6NDC:75990-605-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product06/25/2020
    7NDC:75990-605-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    8NDC:75990-605-121000 mL in 1 BAG; Type 0: Not a Combination Product06/25/2020
    9NDC:75990-605-13800 mL in 1 BAG; Type 0: Not a Combination Product06/25/2020
    10NDC:75990-605-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    11NDC:75990-605-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/25/2020
    Labeler - Certus Medical, Inc. (966433653)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(75990-605)
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