HAND ARMOR (BENZALKONIUM CHLORIDE) LIQUID [HYGENESIS]

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HAND ARMOR (BENZALKONIUM CHLORIDE) LIQUID [HYGENESIS]
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NDC 58590-001-01, 58590-001-02, 58590-001-03
Set ID f9dc5264-3fe7-47de-a2c2-3debade8448a
Category HUMAN OTC DRUG LABEL
Packager HyGenesis
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    For hand sanitizing to decrease bacteria.

  • Warnings

    For external use only.

    When using this product avoid contact with eyes.

    In case of contact, flush eyes with water.

    Stop use and ask a doctor if

    irritation develops or if condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    • Wash hands
    • Rub in 2 to 4 drops
    • For Healthcare, repeat process every 4 hours
  • Inactive ingredients

    Cyclopentasiloxane, Dimethicone Crosspolymer, Octadecyldimethyl Trimethoxysilylproply Ammonium Chloride, PPG-3 Benzyl Ether Ethylhexanoate

  • Questions or commetns?

    248-342-8040

  • image description

  • INGREDIENTS AND APPEARANCE
    HAND ARMOR 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58590-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
    PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58590-001-0121.26 g in 1 BOTTLE; Type 0: Not a Combination Product09/04/2013
    2NDC:58590-001-0285.05 g in 1 BOTTLE; Type 0: Not a Combination Product09/04/2013
    3NDC:58590-001-03170.1 g in 1 BOTTLE; Type 0: Not a Combination Product09/04/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/04/2013
    Labeler - HyGenesis (039503442)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elba, Inc.108428483manufacture(58590-001) , label(58590-001) , pack(58590-001)
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