Label: CAREONE CITRUS FRESH ANTIBACTERIAL HAND- 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 July 19, 2019

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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 (CI 19140), Yellow 6 (CI 15985).

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    CAREONE CITRUS FRESH ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    TANGERINE PEEL (UNII: JU3D414057)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GINGER (UNII: C5529G5JPQ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-303-11333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/18/2019
    Labeler - American Sales Company (809183973)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(41520-303)
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