Your browser does not support JavaScript! FIRST DUKES MOUTHWASH COMPOUNDING (DIPHENHYDRAMINE HYDROCHLORIDE AND HYDROCORTISONE AND NYSTATIN) KIT [CUTISPHARMA, INC.]
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FIRST DUKES MOUTHWASH COMPOUNDING (diphenhydramine hydrochloride and hydrocortisone and nystatin) kit
[CutisPharma, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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

Size8 FL OZ (237 mL)
NDC #65628-052-01
Diphenhydramine HCI0.525 g
Hydrocortisone0.06 g
Nystatin0.6 g
FIRST® – Mouthwash Suspension II236 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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:65628-052
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65628-052-011 in 1 CONTAINER
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, GLASS 0.06 g
Part 21 BOTTLE, GLASS 0.525 g
Part 31 BOTTLE, GLASS 0.6 g
Part 41 BOTTLE, PLASTIC 234 mL
Part 1 of 4
HYDROCORTISONE 
hydrocortisone powder, for suspension
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE0.06 g  in 0.06 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.06 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER
Part 2 of 4
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride powder, for suspension
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE0.525 g  in 0.525 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.525 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER
Part 3 of 4
NYSTATIN 
nystatin powder, for suspension
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NYSTATIN (NYSTATIN) NYSTATIN0.6 g  in 0.6 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.6 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER
Part 4 of 4
FIRST MOUTHWASH SUSPENSION II 
first mouthwash suspension ii suspension
Product Information
Route of AdministrationORALDEA Schedule    
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1234 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/15/2010
Labeler - CutisPharma, Inc. (090598256)
Establishment
NameAddressID/FEIBusiness Operations
ANIP Acquisition Company831049171MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Marlex Pharmaceuticals, Inc782540215REPACK

Revised: 11/2010
 
CutisPharma, Inc.

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