Label: LAFLARE SANTIX ANTIBACTERIAL MOISTURIZING WIPES- benzalkonium chloride liquid

  • 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 May 30, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.1%

  • INACTIVE INGREDIENTS

    Water, Phenoxyethanol, Glycerin, Sodium Benzoate, Polysorbate 20, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Macadamia Integrifolia/Tetraphylla Seed Oil, Anthemis Nobilis Flower Extract, Fragrance

  • PURPOSE

    Antimicrobial

  • WARNINGS

    For external use only.
    --------------------------------------------------------------------------------------------------------
    Do not use
    • in children less than 2 months of age
    • on open skin wounds
    --------------------------------------------------------------------------------------------------------
    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    --------------------------------------------------------------------------------------------------------
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Instant hand antimicrobial to decrease bacteria on the skin

  • Directions

    ■ Wet hands thoroughly with product and allow to dry without wiping

    ■ Do not flush

  • Other information

    Storage in a cool, dry place, Avoid freezing and excessive heat above 40 ℃ (104 ℉)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of container

  • INGREDIENTS AND APPEARANCE
    LAFLARE SANTIX ANTIBACTERIAL MOISTURIZING WIPES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75536-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75536-0005-181 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - NAICO (694725335)
    Registrant - NAICO (694725335)
    Establishment
    NameAddressID/FEIBusiness Operations
    NAICO694725335manufacture(75536-0005)
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