Product Description.:
Active Ingredients:
Progesterone (wettable) ? 6.0 g
Inactive Ingredients:
Fatty acid base ? 63.0 g
Other Components:
30-unit suppository mold with caps Stirrer Suppository filling tool
Guide Plate 30-unit suppository mold cover with suppository dispensing tool attached
To the Pharmacist:
Prior to compounding, storeFIRST - Progesterone VGS Compounding Kits at room temperature between 15?-30?C (59?-86?F) [see USP]. Also, store the compounded suppositories in the 30-unit suppository mold in the refrigerator (2?-8?C [36?-46?F]). FIRST - Progesterone VGS Compounding Kits components have a two-year expiration date.** The preparation of vaginal suppositories using FIRST - Progesterone VGS Compounding Kits complies with the requirements of USP, and as such, compounded suppositories made using FIRST - Progesterone VGS Compounding Kits can be used for up to ninety days after the day on which they were compounded.
When compounded and dispensed according to the instructions, average suppository weight has been found to be 2.3 grams and contain 90?110% of progesterone as labeled.**
The suppository mold and its accessories contained in this kit meet the requirements for USP Cytotoxicity Test, as well as Class VI Tests for plastic containers.**
Instruct patient as follows:
? For vaginal use only
? Do not take orally
? Do not insert in urinary opening or anus
? Avoid contact with eyes
? Keep out of reach of children
? Protect from light
? Keep container tightly closed
? Store suppositories in the mold, in the refrigerator
? Remove red caps from suppositories prior to use
* Certificate of analysis on file
** Data and documentation on file
