Label: ENMOTION ANTIMICROBIAL FOAM WITH MOISTURIZERS TRANQUIL ALOE- benzalkonium chloride solution

  • NDC Code(s): 54622-315-01
  • Packager: Georgia-Pacific Consumer Products
  • 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 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium chloride, 0.13% w/w

  • Purpose

    Antiseptic

  • Use

    Handwash to help reduce bacteria that potentially can cause disease.

  • Warnings

    • For external use only

    When using this product

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

    Stop use

    if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

    If swallowed, seek immediate medical attention or call a poison control center.

  • Directions

    Wet hands, apply soap, rub hands together vigorously for at least 20 seconds.

    Rinse and dry hands thoroughly with a disposable paper towel.

  • Inactive ingredients

    Water (Aqua),Lauramine Oxide, Lauryl Betaine, Laurtrimonium
    Chloride, Glycerin, Sodium PCA, Tocopheryl Acetate,
    Oleth-10, Aloe Barbadensis Leaf Juice, Chamomilla
    Recutita (Matricaria) Extract, Camellia Sinensis Leaf
    Extract, Avena Sativa (Oat) Kernel Extract, Euterpe
    Oleracea Fruit Extract, Tetrasodium EDTA, Citric
    Acid, Fragrance, FD&C Green #5, FD&C Yellow #10

  • PRINCIPAL DISPLAY PANEL

    69050-315 Label

  • INGREDIENTS AND APPEARANCE
    ENMOTION ANTIMICROBIAL FOAM WITH MOISTURIZERS TRANQUIL ALOE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54622-315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    LAURYL BETAINE (UNII: Y4P927Q133)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PIDOLATE (UNII: 1V74VH163T)  
    OLETH-10 (UNII: JD797EF70J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54622-315-012 in 1 BOX06/13/2023
    11200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/13/2023
    Labeler - Georgia-Pacific Consumer Products (806142217)
    Registrant - CYAN Labs S.A. de C.V. (812754130)
    Establishment
    NameAddressID/FEIBusiness Operations
    CYAN Labs S.A. de C.V.812754130manufacture(54622-315)
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