Label: ARIS FOAMING 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 July 10, 2020

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  • Drug Facts

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Antibacterial hand soap

  • Use:

    helps fight germs on hand when used as a hand soap.

  • WARNINGS:

    For external use only.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control centre right away. In case of contact with eyes, rinse thoroughly with water.

  • DIRECTIONS:

    Put a small amount of "Aris Foaming Hand Soap" onto wet palm

    Create a rich lather and scrub your hands for at least 20 seconds. Scrub all the surfaces, palms, backs, fingers, between fingers and under nails.

    Rinse thoroughly with running water

  • INACTIVE INGREDIENTS

    Water, Sodium Lauryl Sulphate, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Glycol Distearate, Glycerin, Aloe Vera, Vitamin E, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, May Contain Yellow 5 (CI 19140), Red 33 (CI 17200), Red 40 (CI 18035), Blue 1 (42090), Ext.Violet 2 (60730).

  • SPL UNCLASSIFIED SECTION

    ANTIMICROBIAL

    ANTIBACTERIAL FDA COMPLIANT

    20 SECOND RULE

    KILLS UP TO 99.99% OF HARMFUL GERMS & BACTERIA*

    TOTAL CLEAN

    2X FORMULA

    SANITIZING HAND SOAP

    KILLS UP TO 99.99% of most common germs that may make you sick

    ariscosmetics.com

    Produced by Winner Manufacturing

    Made in UAE

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ARIS FOAMING HANDSOAP 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79260-487
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79260-487-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    2NDC:79260-487-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/06/2020
    Labeler - WINNER MANUFACTURING (561423928)
    Establishment
    NameAddressID/FEIBusiness Operations
    WINNER MANUFACTURING561423928manufacture(79260-487)
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