Label: LUVONE BODY WASH DAILY MOISTURIZING OATMEAL- 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 July 13, 2021

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  • Drug Facts

  • Active Ingredients

    Benzalkonium Chlorie 0.13%

    Purpose

    Antibacterial

  • Use(S)

    For hand washing to decrease bacteria on the skin.

  • Warning(S)

    For external use only.

    Do not use

    • In children less than 2 months of age.
    • On open skin wounds.

    When using this product

    Avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if

    irritation or redness develops. Conditions persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Pum into hands, wet as nedeed.
    • Lather vigorously for at least 15 seconds
    • Wash skin, rinse thoroughly and dry.
  • Other Information

    • Store at room temperature, in a cool and dry place.
  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl betaine, Glycerin, Sodium laureth sulphate (and) Cocoamido MEA (and) Glycol Stearate (and) Gycol, Sodium Chloride, Lauramidopropylamine Oxide, Coco-Glucoside (and) Glyceryl Oleate, PEG-150 Distearate, Edetate Disodium, Citric Acid, Parfum, Avena sativa extract, DMDM Hydantoin and Iodopropynyl Butylcarbamate, CI 15510.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    LUVONE BODY WASH DAILY MOISTURIZING OATMEAL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80683-002
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80683-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2021
    Labeler - INDUSTRIAS MC CLEAN S A S (886518381)
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