Label: BERKLEY JENSON ANTIBACTERIAL HAND- 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 March 17, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    helps eliminate bacteria on hands.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. In case of contact, rinse with water.

    Stop use and ask a doctor if

    irritation or redness develops and lasts

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    appy onto wet hands. Lather and rinse thoroughly

  • Other information

    store at room temperature.

  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Poloxamer 124, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Sodium Citrate, Camellia Sinensis Leaf Extract, Saccharomyces Ferment, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Niacinamide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

  • Questions or comments?

    1-800-934-1204

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    BERKLEY JENSON ANTIBACTERIAL HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-151-641892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/16/2020
    Labeler - BJWC (159082692)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(68391-151)
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