Label: INSTANT HAND ANTISEPTIC- 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 December 29, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.095%

  • Purpose

    Antiseptic

  • Uses

    To help reduce bacteria on hands.

  • Warnings

    For external use only.

    When using this product avoid contact with eyes and lips. If contact occurs, rinse with water.

    Stop use and ask a doctor if irritation or redness develops.

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

  • Directions

    Rub dime sized amount between hands until dry.

    Children under 6 years of age should be supervised when using this product.

  • Inactive Ingredients

    Glycerin, Methylisothiazolinone, Propylene Glycol, Polyquaternium-37, Triethanolamine. Water

  • SPL UNCLASSIFIED SECTION

    Distributed by :
    ASP Global, LLC
    7800 Third Flag Parkway,
    Austell, GA 30168, USA

  • PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

    ENGLEWOOD
    HEALTH

    Instant Hand Antiseptic

    Alcohol & Fragrance Free

    1.9 FL OZ / 53 mL

    Distributed by :
    ASP Global, LLC
    7800 Third Flag Parkway,
    Austell, GA 30168, USA

    Rev 03

    PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND ANTISEPTIC 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.095 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-002-0153 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2018
    Labeler - ASP Global, LLc (080361159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-002)
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