Label: CAREONE- benzalkonium chloride soap

  • 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 2, 2021

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  • Active Ingredient

    Benzalkonium Chloride (0.13%)

  • Purpose

    Antibacterial

  • Uses

    Helps eliminate bacteria on hands.

  • Warnings

    For external use only.

    When using this Product

    • Avoid contact with eyes. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor if

    • irritation or redness develops and lasts.

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Apply onto wet hands.
    • Lather and rinse thoroughly..
  • Other Information

    Store at Room Temperature

  • Inactive Ingredients

    Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Yellow 6 (Cl 15985).

  • PDP03

    PDP03

  • INGREDIENTS AND APPEARANCE
    CAREONE 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRUS NOBILIS (UNII: 8MFF77J91V)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    DIRECT YELLOW 6 (UNII: 9CU9YEE7RC)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-003-03333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/26/2021
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa Dent Inc203478896manufacture(72476-003)
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