Label: STERIZAR ADVANCED BARRIER CONTROL BACTERICIDAL HAND SANITIZER- benzalkonium chloride gel

  • 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(s)

    Hand Sanitizer Gel. For Hand Sanitizing to Decrease Bacteria On Skin. Safe for Repeated Use. For use when soap and water not available.

  • 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 rash occurs. These may be signs 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

    • Squeeze gently approximately 2 ml (one shot) on physically clean hands.
    • Rub into the hands skin for at least 30 seconds ensuring that all areas are covered until dry.
  • 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, C12-14 Alkyl dimethyl, Decyl Dimethyl Ammonium Chloride, 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 79310-303-22

    STERiZAR®
    Advanced Barrier Control

    Bactericidal
    Hand Gel
    Sanitizer

    Specially formulated to kill
    harmful bacteria

    Effective for at
    least 6 hours
    No need to rinse

    16.9 FL OZ (500 mL)

    ALCOHOL
    FREE

    Kills 99.999% of germs

    • HALAL MONITORING •
    COMMITTEE - UK

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    STERIZAR   ADVANCED BARRIER CONTROL BACTERICIDAL HAND SANITIZER
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79310-303
    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:79310-303-215000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    2NDC:79310-303-22500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    3NDC:79310-303-201000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    4NDC:79310-303-27285 mL in 1 BOTTLE, PUMP; 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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