Label: BELAR ANTIBACTERIAL WHITH CHAMOMILE- benzalkonium chloride liquid

  • NDC Code(s): 79716-000-01
  • Packager: LABORATORIOS BELAR S.A. DE C.V.
  • 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 July 28, 2020

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  • Drug Facts

  • Active Ingredient(s)

    Benzalkonium Chloride 0.10%

    Purpose

    Antibacterial

  • Use(s)

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    Do not use

    • If you are allergic to any component.

    When using this product.

    Avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor.

    If irritation or redness develops.

    Keep out of reach of children.

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

  • Directions

    • Put into DRY Hands
    • Lather vigorously for least 15 seconds
    • Rinse and dry thoroughly
  • Inactive ingredients.

    Destilled Water, Bland LAR®, Chamomile aqueous extract (Chamaemelum nobil), Glycerin, DMDM Hydantoin, fragance.

  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    BELAR ANTIBACTERIAL WHITH CHAMOMILE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79716-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CHAMAEMELUM NOBILE WHOLE (UNII: 7NF3GE7IWR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79716-000-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/20/2020
    Labeler - LABORATORIOS BELAR S.A. DE C.V. (951579919)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS BELAR S.A. DE C.V.951579919manufacture(79716-000)