Mytrophene
Generic name: erythromycin and bacitracin
Dosage form: ointment kit
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.
On This Page
Description
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 u
