Label: A3095-20 SINGLE SHOT EPIDURAL 20G TUOHY - regional anesthesia kit   

  • Label RSS
  • NDC Code(s): 51688-5122-2, 52380-0001-3, 65282-1510-1
  • Packager: Smiths Medical ASD, Inc.
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 01/13

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  • PRINCIPAL DISPLAY PANEL


    3/4 Fluid Ounce Povidone Iodine

    Povidone-iodine 10%

    Antiseptic

    Warnings

                Do not use

    • if allergic to iodine
    • in the eyes

                For external use only

                Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

                Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

                Avoid pooling beneath patient

                Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.


    Povidone Iodine Solution




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  • DESCRIPTION


    Spectra Medical Devices, Inc.
    SODIUM CHLORIDE
    INJECTION, USP, 0.9%

    DESCRIPTION
    Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride 0.9% (9mg/mL) in Water for Injection containing no antimicrobial agent or other added substance.  The pH is between 4.5 and 7.0.  Its chloride and sodium ion concentrates are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL.

    Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste.  Sodium Chloride is freely soluble in water.  It is soluble in glycerin and slightly soluble in alcohol.  The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44.
















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  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY
    Sodium chloride comprises over 90% of the inorganic constituents of the blood serum.  Sodium chloride in water dissociates to provide sodium (Na+) and (Cl-) ions.  These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance.  The small volume of fluid and amount of sodium chloride provided by Sodium Chloride Injection, USP, 0.9% when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in very small infants.

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  • INDICATIONS & USAGE

    INDICATIONS AND USAGE
    Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isontonic single dose vehicle, solvent, or diluent for substances to administered intravenously,k intramuscularly or sub-cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered.

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  • WARNINGS

    WARNING
    Sodium Chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia.

    Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis.  Excessive amounts by parental routes may precipitate congestive heart failure and acute pulmonary edema, especially seen in patients with preexisting cardiovascular disease and those receiving coricos-teroids, corticotrophin or other drugs that may give rise to sodium retention.  For use in newborns, when a Sodium Chloride solution is required for preparation or diluting medications, or in flushing intravenous catheters, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.

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  • PRECAUTIONS

    PRECAUTIONS
    GENERAL

    Since Sodium Chloride Injection does not contain antimicrobial agents and is intended for single use, any unused amount must be discarded immediately following withdrawal of any portion of the contents of the vial or ampul.  Do not open ampul until it is to be used.

    Consult the manufactures instructions for choice of vehicle, appropriate dilution or volume for dissolving the drug to be injected, including the route and rate of injection.

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  • PREGNANCY

    PREGNANCY
    CATEGORY C-
    Animal reproduction studies have not been conducted with Sodium Chloride Injection.  It is also not known whether Sodium Chloride Injection can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity.  Sodium Chloride Injection should be given to a pregnant woman only if clearly needed.

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  • ADVERSE REACTIONS


    ADVERSE REACTIONS
    Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasations.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures and if possible, retrieve and save the remainder of unused vehicle for examination.
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  • OVERDOSAGE

    OVERDOSAGE
    When used as a diluent, solvent or intravascular flushing solution, this parental preparation is unlikely to pose a threat of sodium chloride or fluid overload except possible in very small infants.  In the event these should occur, reevaluate the patient and institute appropriate corrective measures.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION
    Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug;specific references should be checked for any possible incompatibility with sodium chloride.  The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacture.

    Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters.  Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%.  Use in accord with any warnings or precautions appropriate to the medication being administered as recommended by the manufacture.  Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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  • HOW SUPPLIED

    HOW SUPPLIED
    5 mL ampuls packaged in box of 50 each (NDC-65282-1505-1)
    10 mL ampuls packaged in box of 50 each (NDC-65282-1510-1)
    30 mL ampuls packaged in box of 30 each (NDC-65282-1530-3)

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  • STORAGE AND HANDLING

    STORAGE
    Store at controlled room temperature 15-30 C (59-86 F).  Avoid freezing.

    Manufactured for:
    Spectra Medical Devices, Inc. 260-F Fordham Road, Wilmington, MA 01887
    By: KM. Pharm Co., LTD.

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    A3095-20

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  • INGREDIENTS AND APPEARANCE
    A3095-20 SINGLE SHOT EPIDURAL 20G TUOHY 
    regional anesthesia kit kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-5122
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:51688-5122-2 10 in 1 CASE
    1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 PACKET 22.5 mL
    Part 2 1 AMPULE 10 mL
    Part 1 of 2
    APLICARE POVIDONE-IODINE  
    povidone-iodine solution
    Product Information
    Item Code (Source) NDC:52380-0001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) IODINE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    SODIUM PHOSPHATE, DIBASIC  
    SODIUM HYDROXIDE  
    NONOXYNOL-9  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-0001-3 22.5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/01/1984
    Part 2 of 2
    SODIUM CHLORIDE 
    sodium chloride solution
    Product Information
    Item Code (Source) NDC:65282-1510
    Route of Administration EPIDURAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 9 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65282-1510-1 10 mL in 1 AMPULE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/01/2000
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K965017 12/14/2005
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    Name Address ID/FEI Business Operations
    Smiths Medical ASD, Inc. 137835299 relabel, manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aplicare, Inc. 107255002 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Kwang Myung Pharm. Co., Ltd. 631099384 manufacture
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