Label: ANTIBACTERIAL LIQUID HAND- parachlorometaxylenol liquid

  • NDC Code(s): 50241-020-01
  • Packager: Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 12, 2015

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  • Antibacterial Liquid Hand Soap

    image description

    ACTIVE INGREDIENT

    Parachlorometaxylenol 0.3%

    Purpose

    Antibacterial

    USES

    For hand washing to decrease bacteria on the skin

    Warnings For external Use only

    When Using this Product- Avoid contact with the eyes.

    In case of eye contact, fluch eyes with water.

    Stop use and ask a doctor if irritation or redness develops

    or if condition persist for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help

    or contact Posion Control Center right away.

    Directions

    -Pump into hands, wet as needed.

    -Lather skin Vigorously for at least 15 seconds.

    -Wash skin, rinse thoroughly and dry.

    Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glocoside, Glycerine, Aloe Vera, Sodium Chloride, DMDM Hydation, Fragrance, FD&C Blue #1

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL LIQUID HAND 
    parachlorometaxylenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50241-020
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) chloroxylenol 0.30 kg  in 100 kg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYDANTOIN (UNII: I6208298TA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50241-020-01 3.91 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 11/12/2015
    Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
    Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
    Establishment
    Name Address ID/FEI Business Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. 028311595 manufacture(50241-020) , api manufacture(50241-020) , pack(50241-020)
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