PALM (CHLOROXYLENOL) SOAP [CERTUS MEDICAL, INC.]

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PALM (CHLOROXYLENOL) SOAP [CERTUS MEDICAL, INC.]
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NDC 75990-6739-0, 75990-6739-1, 75990-6739-4, 75990-6739-6
Set ID 95a11b85-6cac-4344-a189-cafe45be616d
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

    Chloroxylenol 0.3%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

  • Drug Facts Box OTC-Warnings Section

    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 and forearms
    • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
    • scrub thoroughly for 1 minute and rinse
  • Drug Facts Box OTC-Inactive Ingredient Section

    water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, DMDM hydantoin, methylchloroisothiazolinone, methylisothiazolinone, fragrance, FD and C yellow no.5, food red 10

  • Floren 6739 1000mL

    product label

    Florens 6739 1000mL label

  • INGREDIENTS AND APPEARANCE
    PALM  
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-6739
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ACID RED 1 (UNII: 3365R6427R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75990-6739-61 in 1 BOX08/19/2016
    1800 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:75990-6739-01000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product08/19/2016
    3NDC:75990-6739-41000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
    4NDC:75990-6739-11000 mL in 1 BAG; Type 0: Not a Combination Product08/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/19/2016
    Labeler - Certus Medical, Inc. (966433653)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(75990-6739)
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