Label: OPTIMAL HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 75447-200-02, 75447-200-50
  • Packager: Optisource International Inc.
  • 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 22, 2022

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses • For hand sanitizing to decrease bacteria on the skin • Recommended for repeat use

  • WARNINGS

    Warnings
    For external use only

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hrs.

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

  • DOSAGE & ADMINISTRATION

    Directions • Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands • Rub hands together briskly until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

  • SPL UNCLASSIFIED SECTION

    Alcohol-Free
    Moisturizing

    Kills 99.99% of Germs*

    MADE IN USA

    *of most common germs that may make you sick

    Manufactured by: OptiSource International, Inc.

    Bellport, NY 11713

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    OPTIMAL HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75447-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75447-200-5050 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/09/2020
    2NDC:75447-200-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/09/202012/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2020
    Labeler - Optisource International Inc. (849200159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Optisource International Inc.849200159manufacture(75447-200)
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