Label: AROMATHERAPY RITUALS HAND WASH TEA TREE AND LAVENDER- benzalkonium chloride liquid

  • NDC Code(s): 56136-333-01
  • Packager: Ganzhou Olivee Cosmetic Co., Ltd.
  • 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 June 24, 2020

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  • Drug Facts

  • Active ingredient

    BENZALKONIUM CHLORIDE ......0.13%

  • Purpose

     Antibacterial

  • Use

    • Antiseptic cleanser, for handwashing to decrease bacteria on skin.
  • Warnings

    For external use only.

    Flammable. Keep product away from fire or flame.

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

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

    Other information:

    • Store below 110℉(43℃).
    • May discolor certain fabrics or surfaces.

    Keep out of reach of children.

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

  • Directions

    Adults and children two years of age and older:

    • Pump into dry hands lather vigorously with warm water for at lease 30 seconds.
    • Rinse and dry hands thoroughly for occasional and personal domestic use.
    • Supervise children when they use this product.
  • Inactive ingredients

    Water (Aqua), Lauramine Oxide, Cocamidopropylamine Oxide, Hydroxyethylcellulose, Phenoxyethanol, Benzyl Alcohol, Fragrance (Parfum), Glycerin, Aloe Barbadensis Leaf Extract, Citric Acid, Tocopheryl Acetate (Vitamin E), Melaleuca Alternifolia (Tea Tree) Extract.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    AROMATHERAPY RITUALS HAND WASH TEA TREE AND LAVENDER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-333-01480 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/24/2020
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-333)
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