FIRST® - Mary's Mouthwash Instructions

To the Pharmacist:

Prior to compounding, store FIRST - Mary's Mouthwash Compounding Kit at room temperature not to exceed 25°C (77°F). Store final compounded formulation at refrigerated temperature, 2°-8°C (36°-46°F) [see USP].

FIRST - Mary's Mouthwash Compounding Kit components have a two-year expiration date.* Based on real time refrigerated temperature testing, compounded FIRST - Mary's Mouthwash Compounding product is stable for at least fifteen days.*

* Data and documentation on file

FIRST-MaryÕs Mouthwash Compounding Kit is comprised of 0.45 grams of diphenhydramine hydrochloride powder USP, 0.06 grams of hydrocortisone powder USP, 1.2 grams of nystatin powder USP, and 1.5 grams of tetracycline hydrocohloride powder USP for oral use.

1. FIRST -Mary's Mouthwash Compounding Kit contains premeasured diphenhydramine hydrochloride powder, hydrocortisone powder, nystatin powder, tetracycline hydrochloride powder and Mouthwash Suspension II.

2. Important - Before compounding, shake the FIRST Mouthwash Suspension II bottle for a few seconds. Tap the top and bottom of the nystatin bottle to loosen the powder. Remove the cap and empty the nystatin powder into the mouthwash suspension. Close the suspension bottle and gently shake it back and forth for approx-imately 10 seconds in a horizontal motion on a flat surface in order to sufficiently wet the nystatin powder.

3. Next, vigorously shake the suspension bottle in a vertical motion for at least 60 seconds.

4. Tap the top and bottom of the tetracycline hydrochloride bottle to loosen the powder. Remove the cap and empty the tetracycline hydrochloride powder into the suspension. Close the suspension bottle again and vigorously shake it vertically for approximately 30 seconds.

5. Tap the top and bottom of the diphenhydramine hydrochloride powder bottle to loosen the powder. Remove the cap and because of the hygroscopic nature and small volume of the powder, using the enclosed spatula, empty the contents of the small bottle containing diphenhydramine hydrochloride into the mouthwash suspension. Close the suspension bottle again and vigorously shake it vertically for approximately 30 seconds.

6. Tap the top and bottom of the hydrocortisone powder bottle to losen the powder. Remove the cap and because of the small volume of the powder, using the enclosed spatula, empty the contents of the small bottle containing hydrocortisone into the mouthwash suspension. Close the suspension bottle again and vigorously shake it vertically for approximately 30 seconds.