Label: ANTIBACTERIAL HAND- chloroxylenol soap

  • NDC Code(s): 0404-4438-01, 0404-4438-02, 0404-4438-03
  • Packager: Henry Schein, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Chloroxylenol (PCMX) 0.6%

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  • Purpose

    Antiseptic

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  • Uses

    For handwashing to decrease bacteria on skin. Recommended for repeated use.

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  • Warnings

    For external use only.

    When using this product

    • supervise children under 6
    • do not use in the eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask doctor if irritation or redness develop and persist for more than 72 hours.

    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 and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.

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  • Inactive ingredients

    aloe vera, cocamide DEA, cocamidopropyl betaine, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

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  • PRINCIPAL DISPLAY PANEL – 473 mL (16 fl. oz.) bottle

    Henry Schein

    Antibacterial

    HAND SOAP

    Cucumber & Aloe

    Jabón de manos
    antibacteriano

    Savon antibactérien
    pour les mains

    Distributed by:
    Distribuido por: Distribué par:
    HENRY SCHEIN, Inc.
    135 Duryea Road
    Melville, NY 11747 USA

    16 fl. oz. • 473 ml

    PRINCIPAL DISPLAY PANEL – 473 mL (16 fl. oz.) bottle
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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    chloroxylenol soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0404-4438
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    chloroxylenol (chloroxylenol) chloroxylenol 6.10 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    aloe vera leaf  
    coco diethanolamide  
    cocamidopropyl betaine  
    diazolidinyl urea  
    propylene glycol  
    water  
    sodium chloride  
    sodium laureth-3 sulfate  
    edetate sodium  
    .alpha.-tocopherol acetate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0404-4438-01 0.473 L in 1 BOTTLE
    2 NDC:0404-4438-02 0.237 L in 1 BOTTLE
    3 NDC:0404-4438-03 3.785 L in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/30/2013
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(0404-4438)
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