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Name:Maxitril
Manufacturer:Fusion Pharmaceuticals Llc
Category:Prescription Marketed Drugs


MAXITRIL

MAXITRIL  - erythromycin/bacitracin ointment   
Fusion Pharmaceuticals LLC

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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MAXITRIL

Principal Display Panel

NDC 43093-103-01

Rx only

FusePaq™ Compounding Kit for Topical Ointment

Store kit at room temperature, 15-30°C (59-86°F)

MAXITRIL™

(erythromycin/bacitracin ointment - compounding kit)


Description:
This kit contains active and inactive bulk materials to compound an erythromycin/bacitracin zinc topical ointment. The included instructions describe how to prepare the compounded ointment.



Active Ingredients:

  • 0.31 g erythromycin, USP
  • 28.35 g (1 oz) bacitracin zinc ointment, USP


Inactive Ingredients:

  • Mineral oil, USP
  • Mixing jar
  • Spatula
  • Syringe
  • Instructions

CAUTION: For manufacturing, processing, or repacking. Federal law prohibits dispensing without prescription.

U.S. Patents Pending

Do not use if safety seal is broken

Fusion Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012

CS56-A1 rev 1

Maxitril Box

Drug Label

Do not use if seal is broken

Erythromycin, USP Powder
C37H67NO13 CAS# 114-07-8
Net contents: 0.31 g

Caution: For manufacturing, processing, or repacking
Repackaged by Fusion Pharmaceuticals, LLC, Camarillo, CA 93012

CS53-A1 rev 1

Erythromycin Label

Instructions Insert

NDC 43093-103-01

Rx only

FusePaq™

MAXITRIL™

(erythromycin/bacitracin ointment - compounding kit)


FusePaq™ compounding kits provide a convenient approach to rapidly compound prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practice (cGMP).


For Prescription Compounding Only


Description:


This kit contains active and inactive bulk materials to compound an erythromycin/bacitracin zinc topical ointment. These instructions describe how to prepare approximately 30 grams of ointment.


Active Ingredients:

  • 0.31 g erythromycin, USP
  • 28.35 g (1 oz) bacitracin zinc ointment, USP


Inactive Ingredients:

  • Mineral oil, USP
  • Mixing jar
  • Spatula
  • Syringe
  • Instructions

Instructions for Compounding


1 Remove and Inspect the Contents of the Kit

Ensure that all components are present. Verify that the mixing jar containing the erythromycin is fully sealed. If components are missing or the mixing jar is not sealed, do not use the kit.


2 Prepare for Mixing

Wear gloves and eye protection during compounding operations. Break the seal on the erythromycin mixing jar. Remove the bacitracin zinc ointment tube from its box. Remove the syringe from its packaging.


3 Dissolve the Erythromycin

Open the mineral oil bottle and the erythromycin jar. Using the syringe, withdraw 3 mL of mineral oil. Transfer the 3 mL mineral oil to the erythromycin jar. Using the spatula, mix the mineral oil and the erythromycin powder. Stir the mixture until the erythromycin is fully dissolved.


4 Complete the Mixing Process

Squeeze the entire contents of the bacitracin zinc ointment tube into the mixing jar. Using the spatula, mix the contents. Vary the mixing direction to ensure that the ointment is mixed homogeneously and that all parts of the ointment are included in the mixing process. Homogeneity of the resulting ointment is dependent upon the thoroughness of the mixing process.


5 Re-label the Compounded Ointment

Label the compounded ointment per the pharmacy's standard practice. Remove or obscure the erythromycin label, since the label is no longer accurate once compounding is completed.

Discard the remaining mineral oil.



Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the compounded ointment between 15-30°C (59-86°F).



U.S. Patents Pending


Manufactured by:
Fusion Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012


CS54-A1 rev 1


Insert Page 1

Insert Page 2

Bacitracin Display Panel

E. FOUGERA & CO.
A division of Nycomed US Inc., Melville, New York 11747

Bacitracin Zinc Ointment USP

First Aid Antibiotic NET WT 28.35G (1 Oz)

Bacitracin Display Panel

Bacitracin Drug Facts

NDC 0168-0011-31

Bacitracin Zinc Ointment USP

Drug Facts

Active ingredient (in each gram) Purpose

Bacitracin Zinc (equal to 500 bacitracin units) Antibiotic

Uses first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns


Warnings
For external use only
Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

When using this product do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if a rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage


Other information

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
  • store at room temperature
  • see crimp of tube for Lot No. and Exp. Date


Inactive ingredient white petrolatum


Questions or comments? call toll free 1-800-645-9833

Bacitracin Drug Facts

Mineral Oil Display Panel

Topical Light Mineral Oil USP

(sterile)

NOT FOR PARENTERAL USE

not intended for oral internal use

25mL

THIS PRODUCT IS INTENDED FOR USE AS A TOPICAL LUBRICANT OR TOPICAL DRESSING

Stabilized with Vitamin E
CONTENTS STERILE UNLESS SEAL IS OPENED OR DAMAGED

NDC 54162-185-25

Geritrex Corp:
144 Kingsbridge Road East, Mount Vernon, NY 10550
T: 914.668.4003 F: 914.668.4047
info@geritrex.com | www.geritrex.com

Mineral Oil Display Panel


MAXITRIL 
erythromycin/bacitracin ointment kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43093-103
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43093-103-01 1 KIT ( KIT) in 1 KIT None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 JAR   0.31 g
Part 2 1 BOX   28.35 g
Part 3 1 BOTTLE, GLASS   25 mL
Part 1 of 3
ERYTHROMYCIN 
erythromycin powder
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythromycin (Erythromycin) Erythromycin 0.31 g  in 0.31 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0.31 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/08/2010

Part 2 of 3
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bacitracin Zinc (Bacitracin) Bacitracin Zinc 500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient Name Strength
Petrolatum  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 28.35 g in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/08/2010

Part 3 of 3
LIGHT MINERAL OIL 
light mineral oil liquid
Product Information
Route of Administration TOPICAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
Light Mineral Oil  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 25 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/08/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/08/2010

Labeler - Fusion Pharmaceuticals LLC (021420944)
Establishment
Name Address ID/FEI Operations
Fusion Pharmaceuticals LLC 021420944 repack

Revised: 02/2010 Fusion Pharmaceuticals LLC



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


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