ONYCHO-MED- miconazole nitrate, terbinafine hcl
Medhart Pharmaceuticals, 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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Thank you for choosing Onycho-Med by Medhart Pharmaceuticals, Inc.
To the licensed medical professionals:
“This convenience kit is for prescription compounding only”
Please make sure the kit contains the following components:
One Miconazole Nitrate USP 2% solution in 10ml bottle fitted with a brush cap lid One bottle containing 250 mgs of Terbinafine Hcl USP powder
Acetic Acid, Aqua, Benzyl Alcohol, DMSO, IPA 70%, Laureth-4, PEG-6, Tea Tree Oil
Onycho-Med is a prescription only convenience kit for compounding by a healthcare professional for topical application in management of onychomycosis. The package contains premeasured bottles of Miconazole Nitrate 2% solution * and Terbinafine Hcl USP 250 mg** to make a final volume of 10 ml solution of Miconazole Nitrate 2% and Terbinafine Hcl USP 2.5%.
Prescribed for the management of onychomycosis
Mixing Instructions - Easy Two Step Process
To the licensed medical professionals:
“This convenience kit is for prescription compounding only”
The non-compounded kit has a shelf-life of two years, The final product once mixed will follow a 30 day expiration as per USP 795 BUD (Beyond Use Date) guidelines. Healthcare professionals please follow your local state board of pharmacy BUD guidelines as well. Please discard any unused components of the kit appropriately. Miconazole Nitrate 2% solution meets the requirements for total aerobic microbial count of no more than 100 cfu/gm, as well as for absence of the specified microorganisms Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella and Candida albicans.
The convenience kit and the compounded product can be stored at room temperature between (15 – 30 0c) and after compounding should be discarded after 30 days as per USP 795 guidelines. Protect from light, protect from freezing.
Onycho-Med compounding kit components have a two-year expiration date ***
For External Use Only: Keep container tightly closed, keep out of reach of children, and avoid contact with eyes.
* This product is not manufactured by Valeant Pharma manufacturers of Fungoid tincture
** Certificate of Analysis on file
***Data and documentation on file
Users are encouraged to report adverse events to FDA MedWatch
1-800-FDA-1088 or at http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
RX Only
Revised: April2019
Dear professionals we always value your feedback, please email at: suggestions@medhartpharma.com
Manufactured for:
Medhart Pharmaceuticals, Inc.
50 Eagle Rock Way, Suite C, Brentwood Ca 94513
Ph: 1-833-MEDHART (633-4278)
ONYCHO-MED
miconazole nitrate, terbinafine hcl kit |
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Labeler - Medhart Pharmaceuticals, Inc. (080145788) |