Label: ANTIBACTERIAL- chloroxylenol liquid

  • 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 August 27, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Chloroxylenol 0.3%

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  • Purpose

    Antibacterial

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  • Use

    for handwashing to decrease bacteria on the skin

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  • Warnings

    For external use only: hands only

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  • When using this product

    do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

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  • Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
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  • Inactive ingredients

    water, sodium C14-16 olefin sulfonate, lauramine oxide, sodium laureth sulfate, sodium lauryl sulfate, sodium xylenesulfonate, sodium chloride, alcohol denat., fragrance, phenoxyethanol, citric acid, methylisothiazolinone, tetrasodium EDTA, yellow 5, blue 1

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  • claims

    • Do not add bleach.  
    • Not for use in dishwashers.
    • Contains surfactants
    • Phosphate free
    • This product is not manufactured or distributed by Procter & Gamble, distributor of Dawn Ultra Antibacterial Hand Soap Apple Blossom Scent.

    NOT 100% SATISFIED? Return packaged and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

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  • Adverse reaction

    Distributed By: FAMILY DOLLAR SERVICES INC.

    10401 MONROE RD, MATTHEWS, NC 28105 USA

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  • PRINCIPAL DISPLAY PANEL

    Compare to DAWN Ultra

    100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

    HOMELINE

    ULTRA

    ANTIBACTERIAL

    HAND SOAP

    3X MORE CLEANING POWER

    VS.NON-CONCENTRATED FORMULAS

    CRISP GREEN APPLE SCENT

    DISHWASHING LIQUID

    18 FL OZ (532 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-956
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3.09 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    sodium laureth sulfate (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-956-44 531 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/29/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 04/29/2016
    Labeler - Family Dollar (024472631)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon, Inc 088520668 manufacture(55319-956)
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