BAN-AID (CHLOROXYLENOL) SOAP [PRO CHEM, INC.]

BAN-AID (CHLOROXYLENOL) SOAP [PRO CHEM, INC.]
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NDC 63830-544-06, 63830-544-14
Set ID a251093c-77d1-4a2b-ba3d-e8768656cf6c
Category HUMAN OTC DRUG LABEL
Packager Pro Chem, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • 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, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, food red 10

  • Ban-Aid 1 gallon

    product label

    Ban-Aid  1 gallon

  • INGREDIENTS AND APPEARANCE
    BAN-AID 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63830-544
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63830-544-061 in 1 BOX02/01/2007
    1800 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:63830-544-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2007
    Labeler - Pro Chem, Inc. (061396065)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(63830-544)

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