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Name:First Dukes Mouthwash Compounding
Manufacturer:Cutispharma, Inc.
Category:Prescription Marketed Drugs


FIRST Dukes Mouthwash Compounding Kit

FIRST DUKES MOUTHWASH COMPOUNDING - diphenhydramine hydrochloride and hydrocortisone and nystatin   
CutisPharma, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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FIRST Dukes Mouthwash Compounding Kit

FIRST® – Duke’s Mouthwash Rx

Diphenhydramine HCI, Hydrocortisone, and Nystatin Compounding Kit

FOR PRESCRIPTION COMPOUNDING ONLY

DESCRIPTION

Each FIRST® – Duke’s Mouthwash Compounding Kit is comprised of 0.525 grams of diphenhydramine hydrochloride powder USP, 0.06 grams of hydrocortisone powder USP, and 0.6 grams of nystatin powder USP for oral use. * FIRST® – Duke’s Mouthwash Compounding Kit also contains a 236 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, and nystatin comparable to the active ingredients (diphenhydramine hydrochloride, hydrocortisone, and nystatin oral suspension) contained in Duke’s Magic Mouthwash.

How Supplied and Compounding Directions

Size 8 FL OZ (237 mL)
NDC # 65628-052-01
Diphenhydramine HCI 0.525 g
Hydrocortisone 0.06 g
Nystatin 0.6 g
FIRST® – Mouthwash Suspension II 236 mL

TO THE PHARMACIST

Everything you need to make this Rx is included…

Pharmacist Mixing Directions
Tap the Top, Tap the bottom, shake horizontally, shake vertically
  1. FIRST® - Duke’s Mouthwash Compounding Kit contains premeasured diphenhydramine hydrochloride powder, hydrocortisone powder, nystatin 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 approximately 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 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.
  5. 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, 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® - Duke’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® - Duke’s Mouthwash Compounding Kit components have a two-year expiration date. ** Based on real time refrigerated temperature testing, compounded FIRST® - Duke’s Mouthwash Compounding product is stable for at least thirty 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.

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 30 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

PRINCIPAL DISPLAY PANEL

NDC 65628-052-01 RX ONLY
FIRST® - Duke’s Mouthwash
Diphenhydramine HCI, Hydrocortisone, and Nystatin Compounding Kit
FOR PRESCRIPTION COMPOUNDING ONLY
8 FL OZ (237 mL) as dispensed

PRINCIPAL DISPLAY PANEL
NDC 65628-052-01 RX ONLY
FIRST® - Duke’s Mouthwash
Diphenhydramine HCI, Hydrocortisone, and Nystatin Compounding Kit


FIRST DUKES MOUTHWASH COMPOUNDING 
diphenhydramine hydrochloride and hydrocortisone and nystatin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65628-052
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65628-052-01 1 KIT (1 KIT) in 1 CONTAINER None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, GLASS   0.06 g
Part 2 1 BOTTLE, GLASS   0.525 g
Part 3 1 BOTTLE, GLASS   0.6 g
Part 4 1 BOTTLE, PLASTIC   234 mL
Part 1 of 4
HYDROCORTISONE 
hydrocortisone powder, for suspension
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 0.06 g  in 0.06 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0.06 g in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER

Part 2 of 4
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride powder, for suspension
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 0.525 g  in 0.525 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0.525 g in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER

Part 3 of 4
NYSTATIN 
nystatin powder, for suspension
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NYSTATIN (NYSTATIN) NYSTATIN 0.6 g  in 0.6 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0.6 g in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER

Part 4 of 4
FIRST MOUTHWASH SUSPENSION II 
first mouthwash suspension ii suspension
Product Information
Route of Administration ORAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CARBOXYMETHYLCELLULOSE SODIUM  
PROPYLPARABEN  
WATER  
SACCHARIN SODIUM  
SORBITOL  
FD&C YELLOW NO. 5  
ANHYDROUS CITRIC ACID  
ALCOHOL  
PROPYLENE GLYCOL  
SODIUM CITRATE  
Product Characteristics
Color      Score     
Shape Size
Flavor BANANA Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 234 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/15/2010

Labeler - CutisPharma, Inc. (090598256)
Establishment
Name Address ID/FEI Operations
ANIP Acquisition Company 831049171 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Marlex Pharmaceuticals, Inc 782540215 REPACK

Revised: 11/2010 CutisPharma, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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