GLYSOL-500  - glycerin, sodium lactate and potassium chloride solution 
Biomet Biologics

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Glysol-500

Not for direct intravenous infusion.

For extracorporeal blood processing only. Do not use unless solution is clear.

Each 100ml contains:

Glycerin, U.S.P.                            57.10 g
Sodium Lactate                               1.60 g
Potassium Chloride, U.S.P.                .03 g

Buflered with Sodium Phosphates. Approx. pH 7.0;- Sterile-Non-pyrogenic

Caution: Store Between 15 degree centigrade - 32 degree centigrade (59 degree F - 90 degree F).

enCyte

pn-5500    500ml.

Manufactured for: enCyte Systems, Inc.

55 Messina Drive - Braintree, MA 02184 - USA

1-800-277-1202 - Fax 781-848-6781

Manufactured by: Cytosol Laboratories, Inc.

Braintree, MA 02184 - USA

Rx Only             NDC 23731-5000-5

Exp:

Lot:

GLYSOL-500  glycerin, sodium lactate, potassium chloride   solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 23731-5000 Route of Administration EXTRACORPOREAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 57.10 g  in 100 mL SODIUM LACTATE (SODIUM CATION) SODIUM LACTATE 1.60 g  in 100 mL POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 0.03 g  in 100 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23731-5000-4 400 mL In 1 BOTTLE None 2 23731-5000-5 500 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2010	09/06/2010

Labeler - Biomet Biologics (066629064)

Establishment
Name	Address	ID/FEI	Operations
Biomet Biologics		066629064	manufacture

Revised: 09/2010Biomet Biologics