Application Nr Approved Date Route Status External Links
ANDA065139 2004-12-27 Vaginal RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clindamycin Phosphate Vaginal Cream 2%, Is Indicated In The Treatment Of Bacterial Vaginosis (formerly Referred To As Haemophilus Vaginitis, Gardnerella Vaginitis, Nonspecific Vaginitis, Corynebacterium Vaginitis, Or Anaerobic Vaginosis). Clindamycin Phosphate Vaginal Cream 2%, Can Be Used To Treat Non-Pregnant Women And Pregnant Women During The Second And Third Trimester. (see Clinical Studies.) Note: For Purposes Of This Indication, A Clinical Diagnosis Of Bacterial Vaginosis Is Usually Defined By The Presence Of A Homogeneous Vaginal Discharge That (a) Has A Ph Of Greater Than 4.5, (b) Emits A "fishy" Amine Odor When Mixed With A 10% Koh Solution, And (c) Contains Clue Cells On Microscopic Examination. Gram's Stain Results Consistent With A Diagnosis Of Bacterial Vaginosis Include (a) Markedly Reduced Or Absent Lactobacillus Morphology, (b) Predominance Of Gardnerella Morphotype, And (c) Absent Or Few White Blood Cells. Other Pathogens Commonly Associated With Vulvovaginitis, E.g., Trichomonas Vaginalis, Chlamydia Trachomatis, N. Gonorrhoeae, Candida Albicans, And Herpes Simplex Virus Should Be Ruled Out.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Cetostearyl Alcohol CETOSTEARYL ALCOHOL Unresolved
2. Cetyl Palmitate CETYL PALMITATE Molecular
3. Mineral Oil MINERAL OIL Unresolved
4. Polysorbate 60 POLYSORBATE 60 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , FEED-Feed additives , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Sorbitan Monostearate SORBITAN MONOSTEARATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , FEED-Feed additives FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clindamycin Phosphate