Label: KOSETTE CARE SANITIZER- benzalkonium chloride spray

  • 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 7, 2020

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  • Active Ingredients

    Benzalkonium chloride (0.135%)

  • Purpose

    Antiseptic

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Uses

    To decrease bacteria on the skin when soap and water are not available. Recommended for repeated use.

  • Warnings

    For external use only

    When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water.

    Stop use and ask a doctor if skin irritation or redness develops and lasts.

    Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.

  • Directions

    Spray adequate amount to desired area (clothing or body) at a distance of 6 inches for best result. Avoid spraying onto dark colored clothing.

  • Inactive Ingredients

    Quercus acutissima Sap, Water (Aqua), 1,2-Hexanediol, Propylene Glycol, PEG-60 Hydrogenated Castor Oil, Triethanolamine, Citric Acid, Fragrance (Parfum).

  • Kosette Care Sanitizer Spray

    kosette care

  • INGREDIENTS AND APPEARANCE
    KOSETTE CARE SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79369-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.135 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    QUERCUS ACUTISSIMA WHOLE (UNII: 0TVP714IPW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79369-100-0180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/29/2020
    Labeler - Kosette (011133801)
    Establishment
    NameAddressID/FEIBusiness Operations
    MSP CO., LTD695013758manufacture(79369-100)
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