Label: HEALTHY HANDS FOAMING INSTANT HAND SANITIZER- benzalkonium chloride 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 September 21, 2010

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride, 0.13%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to reduce bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush with water.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Apply one shot to dry hands, rub into skin

    No rinsing required

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Propylene Glycol, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauramine Oxide, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090).

  • PRINCIPAL DISPLAY PANEL

    Healthy Hands

    Foaming Instant Hand Sanitizer

    Sanitizes hands without alcohol

    Read the entire label before using this product.

    Not for Resale 4224MMCA OM911

    To Reorder, Call TOLL-FREE: 1-800-527-9919 FAX: 972-438-0634

    Quality !SO 9001 Assurance

    Manufactured for MULTI-MIST Products

    A Division of NCH Corporation

    Net Contents: 33.8 fl oz/1 L

    container label

  • INGREDIENTS AND APPEARANCE
    HEALTHY HANDS FOAMING INSTANT HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-161-0147 mL in 1 BOTTLE, PUMP
    2NDC:11084-161-271000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2010
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
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