Label: AROMATHERAPY ANTIBACTERIAL HAND WASH CHAMOMILE SCENTED- benzalkonium chloride gel

  • NDC Code(s): 56136-390-01
  • Packager: Ganzhou Olivee Cosmetic Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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 9, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.15%

    Purpose

    Antibacterial

    USE

    Helps eliminate bacteria on hands

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes; in case of contact, flush eyes with water.

    Stop use and ask a doctor if

    • irritation and redness develops and persists.

    Keep out of reach of children.

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

  • Directions

    Apply onto wet hands working into a lather. Rinse thorougly.

  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Hydroxethylcellulose, Fragrance (Parfum), Phenoxyethanol, Bezyl Alcohol, Glycerin, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, D&C Red No. 33 (Cl 17200), FD&C Yellow 5, FD&C Blue No. 1 (Cl 42090), Tocopheryl Acetate (Vitamin E).

  • Hand wash

    label image

  • INGREDIENTS AND APPEARANCE
    AROMATHERAPY ANTIBACTERIAL HAND WASH CHAMOMILE SCENTED 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACETYLTRIETHYL CITRATE (UNII: 5WBR36T90E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-390-01350 mL in 1 BOTTLE; Type 0: Not a Combination Product07/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/09/2020
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-390)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!