Label: GP ENMOTION ANTIMICROBIAL FOAM- benzalkonium chloride solution

  • NDC Code(s): 54622-312-01
  • 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 July 29, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium chloride, 0.13%

  • 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.

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    GP ENMOTION ANTIMICROBIAL FOAM 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54622-312
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OAT (UNII: Z6J799EAJK)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    OLETH-10 (UNII: JD797EF70J)  
    WATER (UNII: 059QF0KO0R)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ACAI (UNII: 46AM2VJ0AW)  
    LAURYL BETAINE (UNII: Y4P927Q133)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54622-312-011200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/29/2021
    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(54622-312)
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