Label: WSNA 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 January 22, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if the condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Pump a small amount of foam onto hands

    Rub thoroughly over all surfaces of both hands

    Rub hands together briskly until dry

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Cetrimonium Chloride, Laurtrimonium Chloride, Glycereth-17 Cocoate, Dihydroxyethyl Cocamine Oxide, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Citric Acid, Dimethicone

  • PRINCIPAL DISPLAY PANEL

    WSNA

    Washington State

    Nurses Association

    byotrol

    ALCOHOL-FREE

    ANTIBACTERIAL FOAMING

    Hand Sanitizer

    Powerful, Long-Lasting and Gentle

    Net Contents: 1.69 fl. Oz. (50ml)

    container label


  • INGREDIENTS AND APPEARANCE
    WSNA HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42719-347
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    C12-15 PARETH-7 (UNII: 3XY03A79QH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42719-347-9950 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/22/2014
    Labeler - Byotrol, Inc. (084600340)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clean Advantage Inc178123832manufacture(42719-347)
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