FDA Label for Onycho-med

Active Ingredients:

1. One Miconazole Nitrate USP 2% solution in 10ml glass bottle fitted with a brush cap 

2. One glass bottle containing 250 mgs of Terbinafine Hcl USP powder

In-Active Ingredients:

Acetic Acid, Aqua, Benzyl Alcohol, DMSO, Isopropyl alcohol 70%, Laureth-4, PEG-6, Tea Tree Oil

How Supplied:

Onycho-Med is a prescription only convenience kit for compounding by a healthcare professional for topical nail 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%.

Indication:

Prescribed for the management of onychomycosis

Mixing Instructions - Easy Two Step Process

• Please check expiration dates listed on the bottles
  
• Inspect product integrity seals on the bottles inside the carton
  
• Take the bottles out of the carton and set aside the carton, as illustrated in the picture to the left
  
• Open the black brush-cap on the Miconazole Nitrate 2% bottle and place it aside for re-use
  
• Carefully un-screw the white cap from the Terbinafine Hcl 250mg bottle and set aside to discard later
  
• Carefully pour the contents of the bottle labelled Miconazole Nitrate USP 2% into the bottle labelled Terbinafine Hcl powder 250mg
  
• Place the black brush-cap on the Terbinafine Hcl 250mg bottle, that now has Miconazole Nitrate USP 2% in it as well and tighten the brush-cap

• Carefully pour the contents of the bottle labelled Miconazole Nitrate 2% into the bottle labelled Terbinafine Hcl powder 250mg - onycho med 01

• Now shake the bottle containing Terbinafine Hcl 250mg USP powder and Miconazole Nitrate USP 2% solution vigorously for 30 seconds
  
• Make sure the contents have dissolved and there is no residue
  
• Apply the pharmacy label to the bottle with final solution
  
• Place the final solution (bottle with black brush cap) back into the carton
  
• Discard the empty bottle of Miconazole Nitrate 2% and the white cap appropriately
  
• Please instruct the patient to “shake well before use”

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.

Storage:

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: [email protected]

Manufactured for:

Medhart Pharmaceuticals, Inc.

50 Eagle Rock Way, Suite C, Brentwood Ca 94513

Ph: 1-833-MEDHART (633-4278)

Principal Display Panel

NDC 71150-0786-10
Rx Only
Onycho-Med
(Terbinafine Hcl USP 2.5% and Miconazole Nitrate 2%)
FOR PRESCRIPTION COMPOUNDING ONLY
Topical Antifungal Nail Solution

PRINCIPAL DISPLAY PANELNDC 71150-0786-10Rx OnlyOnycho-Med(Terbinafine Hcl USP 2.5% and Miconazole Nitrate 2%)FOR PRESCRIPTION COMPOUNDING ONLYTopical Antifungal Nail Solution - onycho med 03