Liveo™ Antifoam C Emulsion

30 percent Simethicone USP, methylcellulose, sorbic acid and water.

Tested according to and complies with all United States Pharmacopeia (USP) requirements for Simethicone emulsions.

Stir or agitate Liveo™ Medical Antifoam C Emulsion before removing it from the shipping container.

Diluting:

Liveo™ Medical Antifoam C Emulsion disperses easily in most room-temperature aqueous systems. It can be added directly to the foam­producing solutions with enough agitation to disperse thoroughly and completely. In operations above 37°C and in formulations where maximum uniformity is essential, Liveo™ Medical Antifoam C Emulsion should be prediluted with cool water before use. Prediluting the emulsion will also maximize its defoaming efficiency. Dilute the required amount of Liveo™ Medical Antifoam C Emulsion with up to 10 volumes of cool water by adding the water slowly to the defoamer with continuous, low­shear mixing. Continue to agitate the material during use.

Concentration:

In general, concentrations of 1 to 50 ppm are sufficient to suppress foaming in most systems. A concentration within this range is suggested initially. Adjustments in concentration may be desirable to determine the appropriate level to use for any particular process or product.

Liveo™ Medical Antifoam C Emulsion complies with all monograph requirements for Simethicone Emulsion USP and is acceptable under Food and Drug Administration Regulation 21 CFR 332.10 as a safe and effective over-the-counter drug for use as an anti-flatulent to alleviate the symptoms of gas associated with heartburn, sour stomach and acid indigestion.

Liveo™ Medical Antifoam C Emulsion may also be used in non standardized foods in amounts up to 33.3 parts per million under FDA Regulation 21 CFR 173.340.

In any application involving the U.S. Food and Drug Administration or any other regulatory agency, it is the user's responsibility to ensure that use of the product complies with the requirements of these agencies.

Liveo™ Medical Antifoam C Emulsion is manufactured, tested and packaged imder strict quality control guidelines at the Healthcare Industries Materials Site(HlMS). The HIMS (Hemlock, Mich.) is dedicated to the production of silicone materials for healthcare applications. It is registered with the U. S. Food and Drug Adminis­tration (FDA) as a drug establishment (CFN 1816403), The site quality system for active pharmaceutical ingredients (APis) is in compliance with current Good Manufacturing Practices, for Bulk Pharmaceutical Products. The site is also ISO regisiered by BSI.

A certification that the product specifications have been met will be supplied upon request.
This Simethicone formulation is qualification tested to requirements of the United States Phannacopoeia (USP). While this monograph can serve as a material screen, it is the user's responsibility to ensure the safety and efficacy of this product for each specific end use pharmaceutical product, medical device or other application.

Liveo™ Medical Antifoam C Emulsion is supplied in 18 and 200 kg containers, net weight.

Storage

To be stored in original unopened containers betwen 5 and 32°C. Avoid freezing.

Shipping Limitation

Liveo™ Medical Antifoam C Emulsion should not be shipped below 0°C. Freeze/thaw cycling may break emulsion.