NDC 43093-106-01
Rx only
FusePaq™
Mytrophene™
(erythromycin/bacitracin ointment kit)
FusePaq™ kits provide a convenient approach to rapidly prepare prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practices (cGMP).
Description:
This kit contains active and inactive bulk materials to prepare approximately 30 grams of erythromycin/bacitracin zinc topical ointment. This kit may only be used for the extemporaneous mixing of these ingredients by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.
Active Ingredients:
- 0.31 g erythromycin, USP
- 28.35 g (1 oz) bacitracin zinc ointment, USP
Inactive Ingredients:
- Mineral oil, USP
- Spatula
- Syringe
- Instructions
Suggested Preparation
Suggested Preparation
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 mixing 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 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 Ointment
Label the ointment as required for prescription products. Ensure that the original erythromycin label is removed or obscured, since the original label is no longer accurate once the ointment is prepared.
Discard the remaining mineral oil, syringe, and spatula.
Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the 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 2
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
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 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
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
Carton Box
NDC 43093-106-01
Rx only
FusePaq™ Kit for Topical Ointment
Store kit at room temperature, 15-30°C (59-86°F)
Mytrophene™
(erythromycin/bacitracin ointment kit)
Description:
This kit contains active and inactive bulk materials to prepare approximately 30 grams of an erythromycin/bacitracin zinc topical ointment. This kit may only be used for the extemporaneous mixing of these ingredients by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.
Active Ingredients:
- 0.31 g erythromycin, USP
- 28.35 g (1 oz) bacitracin zinc ointment, USP
Inactive Ingredients:
- Mineral oil, USP
- Spatula
- Syringe
- Instructions
CAUTION: For manufacturing, processing, repacking, or prescription compounding. 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 2
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 05/15/2010 | ||
| Labeler - Fusion Pharmaceuticals LLC (021420944) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Fusion Pharmaceuticals LLC | 021420944 | manufacture | |
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