Label: SULFUR COLLOID - sulfur colloid injection, powder, lyophilized, for solution

  • NDC Code(s): 51808-220-01
  • Packager: AnazaoHealth Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 1, 2012

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  • DESCRIPTION

    Dear Medical Professional,

    AnazaoHealth Sulfur Colloid Kit consists of three separate nonradioactive components:

    1. A 10 milliliter reaction vial containing: Sodium Thiosulfate, 4.8 mg, Gelatin (Porcine), 3.6 mg and Sodium Edetate, 2.3 mg. The contents of the vial are lyophilized and are under vacuum
    2. Vial A, a 5 ml. vial containing:0.25 N. Hydrochloric Acid. The total volume in this vial is 1.2 mL.
    3. Vial B, a 5 ml. vial containing:Sodium Hydroxide, 12 mg, Sodium Phosphate dibasic,15.7 mg, Sodium Phosphate, monobasic, 48.4 mg, Sterile Water for Injection. The total volume in this vial is 1.2 mL
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  • INDICATIONS AND USAGE

    Tc99m Sulfur Colloid is used in lymphoscintigraphy studies in breast cancer patients, for liver, spleen and bone marrow imaging and gastric transit studies and gastroesophageal reflux.

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  • INSTRUCTIONS

    Preparation of Technetium Tc 99m-Sulfur Colloid:

    1. Collect components: 10 ml. Reaction Vial, Solution A, Solution B, Lead Pig, Boiling Water Bath.
    2. Draw up 1 ml. Solution A. (HCl solution) in syringe.
    3. Draw up 2.5 ml. Tc-99m Pertechnetate containing desired activity, dilute with sterile normal saline if necessary.
    4. Add the 2.5 ml Tc-99m Pertechnetate to the shielded reaction vial.
    5. Immediately add the 1 ml. Solution A.
    6. Vent vial to release excess vacuum. Remove vent before boiling.
    7. Shake gently to mix.
    8. Place shielded vial in boiling water bath for 5 minutes for liver imaging and 3 minutes for lymphoscintigraphy imaging use.
    9. Remove from boiling water and let cool for a few minutes.
    10. Draw up 1 ml. Solution B. (Phosphate Buffer) while reaction vial is cooling
    11. After cooling Reaction vial, add the 1 ml Solution B and shake gently to mix. Caution: be sure vial is cool to avoid excess pressure
    12. Quality control: ITLC-SG in normal saline. Greater than 95% should stay at the origin
    13. Tc 99m  Sulfur Colloid expires 6 hours after mixing
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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    SULFUR COLLOID 
    sulfur colloid injection, powder, lyophilized, for solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-220
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GELATIN (UNII: 2G86QN327L) (GELATIN - UNII:2G86QN327L) GELATIN 4.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM THIOSULFATE (UNII: HX1032V43M) 6 mg
    EDETATE DISODIUM (UNII: 7FLD91C86K) 2.3 mg
    Product Characteristics
    Color      Score score with uneven pieces
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51808-220-01 1 in 1 KIT
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 07/01/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Registrant - AnazaoHealth Corporation (011038762)
    Establishment
    Name Address ID/FEI Business Operations
    AnazaoHealth Corporation 011038762 MANUFACTURE(51808-220)
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