Label: ANTIBACTERIAL LEMON SAGE- benzalkonium chloride liquid

  • NDC Code(s): 50157-452-15
  • Packager: Brands International Corporation
  • 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 7, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient - Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Use for handwashing to decrease bacteria on skin

  • WARNINGS

    for external use only - hands only

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Direction

    * wet hands

    * apply to hands

    * scrub thoroughly

    * rinse thoroughly

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Tetra Sodium EDTA, Methylchloroisothiazolinone, Methylisthiazolinone, Yellow 5, Fragrance (Parfum)

  • PRINCIPAL DISPLAY PANEL

    3

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  LEMON SAGE
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-452
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-452-151480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/06/2022
    Labeler - Brands International Corporation (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corporation243748238manufacture(50157-452)
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