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Name:First Bxn Mouthwash
Manufacturer:Cutispharma, Inc
Category:Prescription Marketed Drugs


FIRST BXN MOUTHWASH - diphenhydramine, lidocaine, 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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FOR PRESCRIPTION COMPOUNDING ONLY

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.

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.

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

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.


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


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

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

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

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

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


FIRST BXN MOUTHWASH 
diphenhydramine, lidocaine, nystatin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65628-051
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65628-051-01 1 KIT (1 KIT) in 1 CONTAINER None
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
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0.47 mL in 1 BOTTLE, GLASS None
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 Multilevel Packaging
1 236 mL in 1 BOTTLE, PLASTIC None
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
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0.06 mL in 1 BOTTLE, GLASS None
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
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0.47 mL in 1 BOTTLE, GLASS None
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 Operations
Marlex Pharamceuticals, Inc 782540215 REPACK
Establishment
Name Address ID/FEI Operations
ANIP Aquisition Company 831049171 MANUFACTURE

Revised: 09/2009 CutisPharma, Inc



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


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