Label: FIRST BXN MOUTHWASH- diphenhydramine, lidocaine, nystatin

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

Drug Label Information

Updated 09/09

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    FOR PRESCRIPTION COMPOUNDING ONLY

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  • DESCRIPTION

    Each FIRST®- BXN Mouthwash Compounding Kit is comprised of 0.2 grams of diphenhydramine hydrochloride powder USP, 1.6 grams of lidocaine hydrochloride powder USP, and 1.6 grams of nystatin powder USP for oral use.1 FIRST®- BXN 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, lidocaine hydrochloride, and nystatin comparable to the active ingredients (Benadryl®, Xylocaine® 2% Viscous and Nystatin Oral Suspension 1:1:1 v/v/v) contained in Magic Mouthwash with Nystatin .2


    1
    Certificate of analysis on file
    2
    This product is not manufactured by Pfizer, Inc., manufacturer of Benadryl ® or by AstraZeneca LP, manufacturer of Xylocaine ® 2% Viscous.
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  • How Supplied and Compounding Directions


      Size

      8 FL OZ (237 mL)   

      NDC#

      65628-051-01

      Diphenhydramine HCI

      0.2 g

      Lidocaine HCI

      1.6 g

      Nystatin

      1.6 g

      FIRST®- Mouthwash Suspension II

      236 mL


    TO THE PHARMACIST

    Everything you need to make this Rx is included...

    1. FlRST®-Mouthwash BXN Compounding Kit contains premeasured diphenhydramine hydrochloride powder, lidocaine hydrochloride powder, nystatin powder, and mouthwash suspension II.

    2. Important - Before dispensing, tap the top and bottom of the bottle containing diphenhydramine hydrochloride to loosen the powder and remove the cap. Empty the diphenhydramine hydrochloride powder into the bottle containing the mouthwash liquid suspension. Likewise, tap the top and bottom of each of the bottles containing the lidocaine hydrochloride and nystatin powders, remove the caps and empty the lidocaine hydrochloride powder and the nystatin powder into the bottle containing the mouthwash liquid suspension. The appropriate quantities of diphenhydramine hydrochloride, lidocaine hydrochloride powder, and the nystatin powder have been packaged in each bottle to deliver the required dosage of each drug. Residual quantities remaining in the bottles after emptying need not be rinsed out.

    3. Close the bottle and shake for 20 to 30 seconds. Instruct the patient to shake bottle well before each use.

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  • STORAGE AND HANDLING

    Prior to compounding, store FIRST®- BXN 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®- BXN Mouthwash Compounding Kit components have a two-year expiration date.3 Based on real time refrigerated temperature testing, compounded FIRST®- BXN Mouthwash Compounding product is stable for at least fifteen days.3

    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.


    3
    Data and documentation on file
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  • WARNINGS

    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.


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  • SPL UNCLASSIFIED SECTION

    Rx ONLY

    Issued: June 2009

    U.S. Patent Pending



    Distributed By:

    CP CUTISPHARMA, INC.

    SMART PRODUCTS FOR SMART PEOPLE®


    Woburn, MA 01801, USA www.cutispharma.com


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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - FIRST Mouthwash BXN, 237 mL

    NDC 65628-051-01

    Rx ONLY

    FIRST BXN Mouthwash
    Diphenhydramine, Lidocaine, and Nystatin Compounding Kit

    Equivalent to active ingredients (Benadryl®, Xylocaine® 2% Viscous and Nystatin Oral Suspension 1:1:1 v/v/v) contained in Magic Mouthwash with Nystatin*


    FOR PRESCRIPTION COMPOUNDING ONLY


    8 FL OZ (237 mL) as dispensed


    *This product is not manufactured or distributed by Pfizer, Inc., manufacturer of Benadryl® or AstraZeneca LP, manufacturer of Xylocaine® 2% Viscous


    FIRST BXN Mouthwash Outer Package Display

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - FIRST Mouthwash Suspension II, Bottle 236 mL


    FIRST® - BXN Mouthwash

    FOR PRESCRIPTION COMPOUNDING ONLY

    Distributed by:
    CUTISPHARMA, INC.
    Woburn, MA 01801 USA

    Manufactured by:
    ANI PHARMACEUTICALS, INC.
    Gulfport, MS 39501 USA

    NET CONTENTS
    236 mL

    ORAL SUSPENSION

    CUTISPHARMA

    FIRST Mouthwash Suspension II, Bottle 236 mL

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Diphenhydramine Hydrochloride, Bottle 0.2 Grams


    FIRST® - BXN Mouthwash

    FOR PRESCRIPTION COMPOUNDING ONLY

    Diphenhydramine Hydrochloride USP (0.2 g)

    Distributed by:
    CUTISPHARMA, Inc.
    Woburn, MA 01801 USA

    Repackaged by:
    MARLEX PHARMACEUTICALS, INC.
    New Castle, DE 19720 USA

    CUTISPHARMA
    ORAL SUSPENSION

    Diphenhydramine Hydrochloride, Bottle 0.2 Grams

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Lidocaine Hydrochloride, Bottle 1.6 Grams


    FIRST® - BXN Mouthwash

    FOR PRESCRIPTION COMPOUNDING ONLY
    Lidocaine Hydrochloride USP (1.6 g)

    Distributed by:
    CUTISPHARMA, INC.
    Woburn, MA 01801 USA

    Repackaged by:
    MARLEX PHARMACEUTICALS, INC.
    New Castle, DE 19720 USA

    CUTISPHARMA
    ORAL SUSPENSION

    Lidocaine Hydrochloride, Bottle 1.6 Grams

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Nystatin, Bottle 1.6 Grams


    FIRST® - BXN Mouthwash

    FOR PRESCRIPTION COMPOUNDING ONLY
    Nystatin USP (1.6 g)

    Distributed by:
    CUTISPHARMA, INC.
    Woburn, MA 01801 USA

    Repackaged by:
    MARLEX PHARMACEUTICALS, INC.
    New Castle, DE 19720 USA

    CUTISPHARMA
    ORAL SUSPENSION

    Nystatin, Bottle 1.6 Grams

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  • INGREDIENTS AND APPEARANCE
    FIRST BXN MOUTHWASH 
    diphenhydramine, lidocaine, nystatin kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65628-051
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65628-051-01 1 in 1.0 CONTAINER
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, GLASS 0.47 mL
    Part 2 1 BOTTLE, PLASTIC 236 mL
    Part 3 1 BOTTLE, GLASS 0.06 mL
    Part 4 1 BOTTLE, GLASS 0.47 mL
    Part 1 of 4
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride powder, for suspension
    Product Information
    Item Code (Source) NDC:65628-051
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 6.75 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.47 mL in 1.0 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved other
    Part 2 of 4
    FIRST MOUTHWASH SUSPENSION II 
    first mouthwash suspension ii suspension
    Product Information
    Item Code (Source) NDC:65628-051
    Route of Administration ORAL DEA Schedule     
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    ALCOHOL  
    CARBOXYMETHYLCELLULOSE SODIUM  
    CITRIC ACID  
    FD&C YELLOW NO. 5  
    PROPYLPARABEN  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM  
    TRISODIUM CITRATE DIHYDRATE  
    SORBITOL  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BANANA (BANANA) , VANILLA (VANILLA) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 236 mL in 1.0 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved other
    Part 3 of 4
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride powder, for suspension
    Product Information
    Item Code (Source) NDC:65628-051
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 0.84 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.06 mL in 1.0 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved other
    Part 4 of 4
    NYSTATIN 
    nystatin powder, for suspension
    Product Information
    Item Code (Source) NDC:65628-051
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NYSTATIN (NYSTATIN) NYSTATIN 6.75 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.47 mL in 1.0 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved other
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved other 09/08/2009
    Labeler - CutisPharma, Inc (090598256)
    Registrant - Marlex Pharamceuticals, Inc (782540215)
    Establishment
    Name Address ID/FEI Business Operations
    Marlex Pharamceuticals, Inc 782540215 REPACK
    Establishment
    Name Address ID/FEI Business Operations
    ANIP Aquisition Company 831049171 MANUFACTURE
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