Label: HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 0404-4445-01, 0404-4445-02
  • 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

    Benzalkonium Chloride 0.39%

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  • Purpose

    Antiseptic

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  • Uses

    • for handwashing to decrease bacteria on skin without soap and water
    • recommended for repeated use
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  • Warnings

    For external use only. Flammable, keep away from fire or flame

    Do not use in the eyes. If this happens, rinse thoroughly with water

    Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours

    Keep out of reach of children

    If ingested get medical help or contact a Poison Control Center right away

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  • Directions

    • wet hands thoroughly with product
    • allow to dry without wiping
    • children under 6 should be supervised while using this product
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  • Inactive Ingredients

    aloe vera, propylene glycol, fragrance, purified water, germaben II, ganex p-904 LC

    Distributed by:

    Distribuido por:      Distribuépar:
    HENRY SCHEIN, Inc.

    135 Duryea Road
    Melville, NY 11747 USA

    Made in U.S.A.

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  • PRINCIPAL DISPLAY PANEL – 50 mL Bottle Label

    Henry Schein

    Hand Sanitizer

    Mountain Meadow

    Jabón higiénico
    de manos

    Désinfectant pour
    les mains

    Foaming

    Alcohol Free

    1.7 fl. oz. (50 ml)

    PRINCIPAL DISPLAY PANEL – 50 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0404-4445
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    benzalkonium chloride (benzalkonium) benzalkonium chloride 7.49 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    water  
    aloe vera leaf  
    propylene glycol  
    diazolidinyl urea  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0404-4445-01 0.05 L in 1 BOTTLE, PUMP; Combination Product Type = C112160
    2 NDC:0404-4445-02 0.55 L in 1 BOTTLE, PUMP; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 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(0404-4445)
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