Label: HAND PROTECTOR- benzalkonium chloride solution

  • 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 September 15, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose: Antiseptic. Hand and skin sanitizer.

  • INDICATIONS & USAGE

    USES: to reduce bacteria on skin that could cause disease. Recommended for repeat use.

  • WARNINGS

    WARNINGS

    For external use only.
    Do not use in eyes.
    When using this product avoid contact with eyes. In case of eye contact flush with water. Stop use and ask doctor if irritation and redness develop.
    Keep out of reach of children.
    If swallowed, get medical attention or contact a Poison Control Center.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WHEN USING

    Avoid contact with eyes. In case of eye contact flush with plenty of water.

  • STOP USE

    Stop use and ask doctor if irritation or redness develop.

  • INACTIVE INGREDIENT

    3-(trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Ethyl Alcohol, Water

  • DOSAGE & ADMINISTRATION

    Apply liberally to hands and gently rub until dry. Reapply after 4 hours.

  • QUESTIONS

    Contact:

    Cytonix LLC, Beltsville, MD

    20705 USA 301-470-6267

    www.cytonix.com

  • PRINCIPAL DISPLAY PANEL

    Hand Protector label 79291-653-03 16oz (473mL)

    Hand Protector label 79291-653-03 16oz(473mL)

  • INGREDIENTS AND APPEARANCE
    HAND PROTECTOR 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79291-653
    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) 84 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79291-653-01120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2020
    2NDC:79291-653-02473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
    3NDC:79291-653-03473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - Cytonix, LLC (831532705)
    Registrant - Elaine Lanza (831532705)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cytonix, LLC831532705manufacture(79291-653)
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