SUTURE SYRINGE MEDIC (BENZALKONIUM CHLORIDE, ALCOHOL) KIT [TENDER CORPORATION]

SUTURE SYRINGE MEDIC (BENZALKONIUM CHLORIDE, ALCOHOL) KIT [TENDER CORPORATION]
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NDC 44224-0468-1, 52124-0001-1, 52124-0017-1
Set ID 4adc5dc0-4386-478c-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Tender Corporation
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient - Antiseptic

    Benzalkonium Chloride 0.13%

  • Purpose - Antiseptic

    Antiseptic

  • Use - Antiseptic

    For Professional and hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

  • Warnings, Precautions and Directions - Antiseptic

    For External use only.

    Keep out of Reach of Children.

    Stop use if unusual redness, swelling or other symptoms occur, consult a physician immediately.

    Do not uses in eyes or over large areas of the body.

    Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

  • Inactive Ingredients - Antiseptic

    Purified Water

  • Active Ingredient - Alcohol Prep Pad

    Isopropyl Alcohol 70%

  • Use - Alcohol Prep Pad

    For preparation of the skin before injection

  • Warnings, Precautions and Directions - Alcohol Prep Pad

    For External Use Only

    Flammable - Keep away from fire or flame

    Do Not Use - with electrocautery, in eyes

    Stop Use and Ask a Doctor if - Irritation or redness develop and 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.

    Tear Open packet, unfold and use as and wipe injection site vigorously and discard.

    Store at Room Temperature

  • Keep out of Reach of Children

    Keep out of Reach of Children

  • PRINCIPAL DISPLAY PANEL

    AntisepticAlcohol Prep PadSuture Medic

  • INGREDIENTS AND APPEARANCE
    SUTURE SYRINGE MEDIC 
    benzalkonium chloride, alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-0468
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-0468-11 in 1 BOX; Type 0: Not a Combination Product10/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 PACKAGE 3 mL  in .7 
    Part 24 PACKAGE 3 mL  in .8 
    Part 1 of 2
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0017-10.7 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2016
    Part 2 of 2
    ANTISEPTIC 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:52124-0001
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0001-10.8 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2015
    Labeler - Tender Corporation (064437304)
    Registrant - Tender Corporation (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(44224-0468)

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