Label: BYOTROL HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 63002-002-12, 63002-002-50, 63002-002-75, 63002-002-99
  • Packager: Advanced Hygienics LLC
  • 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 December 14, 2017

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

  • QUESTIONS

    Questions? 1-866-443-4509

  • PRINCIPAL DISPLAY PANEL

    byotrol

    ANTIBACTERIAL FOAMING

    HAND SANITIZER

    ALCOHOL FREE  KILLS GERMS

    POWERFUL

    LONG LASTING

    GENTLE

    Net Contents: 16.9 FL OZ (500mL)

    container label

  • INGREDIENTS AND APPEARANCE
    BYOTROL HAND SANITIZER  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63002-002
    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:63002-002-9950 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2014
    2NDC:63002-002-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2014
    3NDC:63002-002-121250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2014
    4NDC:63002-002-759463 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/02/2014
    Labeler - Advanced Hygienics LLC (065359009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(63002-002)
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