Label: BYOTROL ANTIBACTERIAL FOAMING 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 March 8, 2013

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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 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

    100%

    Hygeine

    Revolution

    Byotrol

    Alcohol Free

    Kills Germs

    Antibacterial Foaming

    Hand Sanitizer

    Powerful

    No other FDA compliant hand antiseptic claims more.

    Long Lasting

    Foaming formula lasts, increasing wet contact time, to deliver the persistent performance Byotrol is known for.

    Gentle

    Alcohol Free Formula is hard on germs and soft on hands.

    byotrol

    Net Contents: 42.26 fl.Oz. (1,250ml)

    container label


  • INGREDIENTS AND APPEARANCE
    BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42719-346
    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)  
    C12-15 PARETH-7 (UNII: 3XY03A79QH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42719-346-50500 mL in 1 BOTTLE
    2NDC:42719-346-51210 mL in 1 BOTTLE
    3NDC:42719-346-9950 mL in 1 BOTTLE
    4NDC:42719-346-061250 mL in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/08/2013
    Labeler - Byotrol, Inc. (084600340)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayscience Formulators Inc.162930544manufacture(42719-346)
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