Label: GENRX HAND SANITIZING- benzalkonium chloride spray

  • 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 March 18, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • Uses

    ■ a topical antiseptic that protects against germs

  • Warnings

    For external use only

  • Do not use on

    ■ deep or puncture wounds ■ animal bites ■ serious burns

  • When using this product

    ■ do not get into eyes

  • Stop use and ask a doctor if

    ■ Irritation and redness develop
    ■ condition persists for more than 72 hours

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ wet hands thoroughly with product
    ■ allow to dry without wiping
    ■ repeat as necessary

  • Other information

    ■ protect from freezing ■ avoid excessive heat

  • Inactive ingredients

    Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, disodium EDTA, glycerin, phenoxyethanol,

    purified water, sodium hyaluronate.

  • GenRx Hand Sanitizing Spray (8 oz label)

    Label

  • INGREDIENTS AND APPEARANCE
    GENRX HAND SANITIZING 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-315-16237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/18/2020
    Labeler - PureTek Corporation (785961046)
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