Label: STERIZAR ADVANCED BARRIER CONTROL- benzalkonium chloride soap

  • 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 January 14, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Benzalkonium Chloride 1.6 %

  • Purpose

    Antiseptic

  • Use

    Sanitizing Hand Wash for Hand Washing to Decrease Bacteria on Skin. For Repeated Use.

  • Warnings

    For external use only. Keep away from heat. Flammable, Keep Away from Heat and Flame

    Do not use

    • On open skin wounds

    When using this product keep out of eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rush occurs These may be sign of serious medical conditions.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away at 1-800-222-1222

  • Directions

    • Apply a small amount of product to the hands and rub in well, paying particular attention to fingernails and the area between the fingers.
    • Allow hands to air dry.
    • Important- the use of towels or tissue may lead to recontamination with bacteria.
  • Other information

    • Store in cool dry area.
    • Avoid freezing
    • Store at 15-30 C (59-86F) Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Amines, Blue Dye,C12-14 Alkyl dimethyl, Decyl Dimethyl Ammonium Chloride, Fragrance, N-oxides, Purified Water, Sodium Ethyl Hexyl Sulfate.

  • SPL UNCLASSIFIED SECTION

    Imported and distributed by
    Unicorn Media Partners LLC
    41 E. Sunrise Hwy.
    Lindenhurst, NY 11757

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    NDC 79310-302-22

    STERiZAR®
    Advanced Barrier Control

    Antibacterial
    Sanitizing
    Hand Wash

    Specially formulated to kill
    harmful bacteria

    ALCOHOL
    FREE
    Kills 99.999% of germs

    2 Hours
    Protection after Rinsing

    16.9 FL OZ (500 mL)

    • HALAL MONITORING •
    COMMITTEE - UK

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    STERIZAR   ADVANCED BARRIER CONTROL
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79310-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride16 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    SODIUM ETHASULFATE (UNII: 12838560LI)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79310-302-22500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    2NDC:79310-302-215000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2020
    3NDC:79310-302-27285 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2020
    Labeler - Unicorn Media Partners LLC (117525623)
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