Label: FIRST DUKES MOUTHWASH COMPOUNDING- diphenhydramine hydrochloride and hydrocortisone and nystatin   

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  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/10

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  • SPL UNCLASSIFIED SECTION

    FIRST® – Duke’s Mouthwash Rx

    Diphenhydramine HCI, Hydrocortisone, and Nystatin Compounding Kit

    FOR PRESCRIPTION COMPOUNDING ONLY

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  • 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.

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  • 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
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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    FIRST DUKES MOUTHWASH COMPOUNDING 
    diphenhydramine hydrochloride and hydrocortisone and nystatin kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65628-052
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65628-052-01 1 in 1 CONTAINER
    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
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.06 g in 1 BOTTLE, GLASS
    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
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.525 g in 1 BOTTLE, GLASS
    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
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.6 g in 1 BOTTLE, GLASS
    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 Marketing Start Date Marketing End Date
    1 234 mL in 1 BOTTLE, PLASTIC
    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 Business Operations
    ANIP Acquisition Company 831049171 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Marlex Pharmaceuticals, Inc 782540215 REPACK
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