Add the following:
Calamine Topical Suspension
(Monograph under this new title—to become official July 1,2007)
(Current monograph title is Calamine Lotion)
»Prepare Calamine Topical Suspension as follows.
Calamine 80g
Zinc Oxide 80g
Glycerin 20mL
Bentonite Magma 250mL
Calcium Hydroxide Topical Solution,a sufficient quantity to make 1000mL
Dilute the Bentonite Magma with an equal volume of Calcium Hydroxide Topical Solution.Mix the powders intimately with the Glycerin and about 100mLof the diluted magma,triturating until a smooth,uniform paste is formed.Gradually incorporate the remainder of the diluted magma.Finally add enough Calcium Hydroxide Topical Solution to make 1000mL,and shake.
If a more viscous consistency in the Calamine Topical Suspension is desired,the quantity of Bentonite Magma may be increased to not more than 400mL.
NOTE—Shake the Calamine Topical Suspension before dispensing.
Packaging and storage— Preserve in tight containers.
Microbial limits á61ñ It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.USP28
(Official July 1,2007)
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 315
Pharmacopeial Forum:Volume No.30(2)Page 467
Phone Number:1-301-816-8389