Label: HANDS FIRST TM- 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 October 28, 2021

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use

    • For handwashing to decrease bacteria on the skin
    • For temporary protection of minor cuts, scrapes, burns and chapped or cracked skin
  • Warnings

    • For external use only.
    • Keep out of the reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
    • Do not use in the eyes.
    • Do not use on deep or puncture wounds, animal bites or serious burns.
    • Extended use may increase risk of sunburn.
  • Stop use and ask a doctor if:

    • symptoms worsen, last for more than seven days, or new symptoms occur at any time
  • Direction

    • Uses as needed.
    • Remove cap and pump foam into palm of hands.
    • Rub foam onto hands.
    • Allow to air dry.
  • Other information

    • save carton for full directions and warnings
    • store between 20 to 25oC (68 to 77oF)
  • Inactive ingredients

    water, cocamidopropyl betaine , allantoin, glycolic acid, dimethicone, aloe vera leaf, lavender extract, colloidal silver, tetrasodium EDTA, phenoxyethanol, ethylhexyl glycerine.

  • Questions?

    Call 1-800-603-0589 between 9am and 5pm (EST) Monday through Friday or visit www.handsfirst.com

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

  • DOSAGE & ADMINISTRATION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Hands First

    4 in 1 action

    Alcohol Free Spray

    Hand Sanitizer

    Doctor created and hospital tested

    Sanitize anytime, anywhere

    Temporarily protect minor cuts and scrapes

    Hydrate your skin

    Clean without water

    Kills 99.99% of germs

    4 fl oz (118mL)

    foam
  • INGREDIENTS AND APPEARANCE
    HANDS FIRST TM 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81858-042
    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
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILVER (UNII: 3M4G523W1G)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81858-042-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    2NDC:81858-042-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    3NDC:81858-042-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    4NDC:81858-042-07207 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    5NDC:81858-042-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    6NDC:81858-042-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/07/2021
    Labeler - Hands First, LLC. (117961848)
    Registrant - Hands First, LLC. (117961848)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hands First, LLC.117961848MANUFACTURE(81858-042)
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