Label: HAND SANITIZER- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 30, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.39%

  • Purpose

    Antiseptic

  • Uses

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

  • Directions

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

  • 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
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-4445
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride7.49 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-4445-010.05 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:0404-4445-020.55 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/30/2013
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0404-4445)
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