Label: KOSETTE SANITIZER WIPES- 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 May 19, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.1%

  • INACTIVE INGREDIENT

    Water, Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Tocopheryl acetate, Citric acid

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    ■ Instant hand antiseptic to decrease bacteria on the skin

  • WARNINGS

    Warnings


    For external use only


    Stop use and ask a doctor if
    ■ hypersensitivity symptoms such as erythema, itching and dermatitis happen
    ■ skin irritation happens


    Do not use
    ■ in combination with soap or antibacterial cleansing agents
    ■ the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin


    When using this product
    ■ avoid using repeatedly in the same area, skin irritation may occur
    ■ avoid getting into the eyes (if contact occurs, wash well with clean water)
    ■ if following abnormal symptoms persist, discontinue use: Irritation around the eyes, ears, mucous membranes, including the mouth, skin irritation, and rashes

  • Directions

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

    ■ Do not flush

  • Other information

    ■ Read the directions and warnings before use ■ Avoid freezing and excessive heat above 40 ℃ (104 ℉)

  • Package Label - kosette SANITIZER WIPES / 108g(20wipes)

    Image of container

  • Package Label - kosette SANITIZER WIPES / 432g(80wipes)

    Image of container

  • INGREDIENTS AND APPEARANCE
    KOSETTE SANITIZER WIPES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73923-0110
    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)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73923-0110-1108 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/2020
    2NDC:73923-0110-2432 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 - FIRSTCHAM CO., LTD (689905446)
    Registrant - FIRSTCHAM CO., LTD (689905446)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRSTCHAM CO., LTD689905446manufacture(73923-0110)
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