Onycho-Med

Generic name: miconazole nitrate, terbinafine
Dosage form: kit

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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:

Active Ingredients:

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

In-Active Ingredients:

Acetic Acid, Aqua, Benzyl Alcohol, DMSO, IPA 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 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 lid 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 2% into the bottle labelled Terbinafine Hcl powder 250mg
  
• Place the black brush-cap lid on the Terbinafine Hcl 250mg bottle, that now has Miconazole Nitrate 2% in it as well and tighten the lid

To the licensed medical professionals:

“This convenience kit is for prescription compounding only”

• Now shake the bottle containing Terbinafine Hcl 250mg USP powder and Miconazole Nitrate 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”

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