FIRST Marys Mouthwash Compounding

CutisPharma, Inc.

FIRST Marys Mouthwash

FULL PRESCRIBING INFORMATION

FIRST ^® – Mary ’s Mouthwash Rx

Diphenhydramine HCI, Hydrocortisone, and Nystatin , and Tetracycline HCI Compounding Kit

FOR PRESCRIPTION COMPOUNDING ONLY

Each FIRST^® – Mary’s 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 hydrochloride powder USP for oral use. * FIRST^® – Mary’s Mouthwash Compounding Kit also contains a 234 mL suspension containing benzyl alcohol, carboxymethycellulose sodium, citric acid (anhydrous), dehydrated alcohol, FD&C yellow #5, flavors, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate (dihydrate), and sorbitol solution. When compounded, the final product provides an homogeneous suspension containing diphenhydramine hydrochloride, hydrocortisone, nystatin, and tetracycline hydrochloride comparable to the active ingredients (diphenhydramine hydrochloride, hydrocortisone, nystatin oral suspension, and tetracycline hydrochloride) contained in Mary ’s Magic Mouthwash.

Everything you need to make this Rx is included…

FIRST® - Mary’s Mouthwash Compounding Kit contains premeasured diphenhydramine hydrochloride powder, hydrocortisone powder, nystatin powder, tetracycline hydrochloride powder and Mouthwash Suspension II. 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 approximately 10 seconds in a horizontal motion on a flat surface in order to sufficiently wet the nystatin powder. Next, vigorously shake the suspension bottle in a vertical motion for at least 60 seconds. 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. 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. Tap the top and bottom of the hydrocortisone powder bottle to loosen 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. The appropriate quantities of nystatin, tetracycline hydrochloride, diphenhydramine hydrochloride, and hydrocortisone powders have been packaged in each bottle to deliver the required dosage of each drug. Powder remaining in the bottles after emptying need not be rinsed out. Instruct the patient to shake the bottle well before each use.

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. **

Mouthwash Suspension II meets the requirements for total aerobic microbial count of not more than 100 cfu/mL, as well as for the absence of the specified microorganisms Escherichia coli, Pseudomonas aeruginosa , Staphylococcus aureus , and Salmonella ssp. when tested as described in the current USP under <61> Microbial Enumeration Tests and <62> Tests for Specified Microorganisms. Mouthwash Suspension II also meets the requirements as described in the current USP under <51> Antimicrobial Effectiveness Testing for Category 2 and Category 3 products.

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOO D TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia also has been reported. TETRACYCLINE DRUGS THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POSTEXPOSURE), UNLESS OTHER DRUGS ARE LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

For oral use only. Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Protect from light. Protect from freezing. Compounded product, as dispensed, is stable for at least 15 days at refrigerated temperature.

*       Certificate of analysis on file

**       Data and documentation on file

Rx ONLY
Issued: June 2010
U.S. Patent Pending

Distributed By:

CutisPharma, Inc.

SMART PRODUCTS FOR SMART PEOPLE ^®

Woburn, MA 01801, USA www.cutispharma.com

NDC 65628-053-01 RX ONLY
FIRST® - Mary’s Mouthwash
Diphenhydramine HCI, Hydrocortisone, Nystatin, and Tetracycline HCi Compounding Kit
FOR PRESCRIPTION COMPOUNDING ONLY
8 FL OZ (237 mL) as dispensed