Cold Cream Form
Cold Cream Form
Cold Cream Form
Name: Strength: Dosage Form: Route of Administration: Cold Cream Base cream Topical
Date of Last Review or Revision: 08/18/05 Person Completing Last Review or Revision: Robert Shrewsbury
120 g
stiffening agent
mineral oil
560 g
5g 190 ml
internal laxative; external emollient, texturing agent preservative; alkalizing agent vehicle
Example Calculations: Specific gravity of mineral oil = 0.88 Equipment Required: Class A prescription balance hotplate, thermometer 2 small beakers glass stirring rod
Method of Preparation: 1. Using the prescription balance, weigh the solid ingredients. 2. If necessary, reduce the cetyl esters wax and the white wax to small pieces. 3. Melt the cetyl esters wax and the white wax in a beaker using a hot plate. 4. Add the mineral oil and continue heating the mixture until it reaches 70C. 5. Dissolve the sodium borate in the purified water, which has been warmed in a second beaker to 70C. 6. Add the warm aqueous mixture gradually to the melted oleaginous mixture. 7. Remove the resulting mixture from the heat; stir rapidly and continuously until the mixture has congealed. 8. Package in ointment jar. Provide a professional finish.
Description of Finished Product: Uniform, luminescent white cream with no visible particles; spreads easily without a gritty texture. Special Note: Product will not reach final form for several hours.
Quality Control Procedures: Observations for uniform consistency Weight of final product.
Beyond-Use Date Assignment: USP Guidelines: All other formulations (i.e., not a solid, not a liquid): Thirty days or intended duration of therapy, whichever is less.
Literature Information: Applied Pharmaceutics and Contemporary Compounding, Chapter 9, Dermatological Formulations: Ointments and Pastes.