Label: MANOLIA ANTIBACTERIAL HANDSOAP- 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 October 24, 2020

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  • USE

    For hand washing to decrease bacteria on the skin. Recommended for repeated use

  • WARNINGS

    For external use only

    When using the product; avoid contact with eyes, In case of eye contact, flush with water.

    Keep out reach of children; If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Pump into hands and wet as needed. Lather vigorously for at least 15 seconds. Wash skin, rinse thoroughly and dry.

  • Active Ingredient(s)

    Benzalkonium Chloride 0.1% Purpose Antiseptic

  • Inactive Ingredients

    Aqua, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Cocamidopropyl Betain, Styrene/acrylates copolymer, Parfum, Glycerin, Polyquternium-7, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Citcic Acid, Benzophenone-4, Cl42090, Cl 19140

  • Keep out of reach of children

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

  • Purpose

    Antiseptic

  • Package Label - Principal Display Panel

    PACKAGE400 ML Ndc : 80887-005-01

  • INGREDIENTS AND APPEARANCE
    MANOLIA ANTIBACTERIAL HANDSOAP 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80887-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDE (UNII: 3YXD33R71G) 1 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 100 mL
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) 1 g  in 100 mL
    CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 g  in 100 mL
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) 1 g  in 100 mL
    BENZOPHENONE-5 (UNII: 853Z42ZYAS) 1 g  in 100 mL
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g  in 100 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 1 g  in 100 mL
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g  in 100 mL
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) 1 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g  in 100 mL
    CHLORINE (UNII: 4R7X1O2820) 1 g  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80887-005-01400 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2020
    Labeler - TELLINI INC. (117014846)
    Registrant - TELLINI INC. (117014846)
    Establishment
    NameAddressID/FEIBusiness Operations
    BSK GRUP KIMYA SANAYI VE TICARET LIMITED SIRKETI595676471manufacture(80887-005)
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