Label: CAREONE SPRING SHOWER- 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 14, 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 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, Lauramine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Benzoate, Blue 1 (Cl 42090), Red 33 (Cl 17200).

  • PDP03

    PDP03

  • INGREDIENTS AND APPEARANCE
    CAREONE SPRING SHOWER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-006
    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
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-006-03222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2021
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa Dent Inc203478896manufacture(72476-006)
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