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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”

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: suggestions@medhartpharma.com

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 Solution

Onycho-Med
miconazole nitrate, terbinafine hcl kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:71150-786
Packaging
# Item Code Package Description
1 NDC:71150-786-10 1 KIT in 1 BOX
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 250 mg
Part 2 1 BOTTLE, WITH APPLICATOR 10 mL
Part 1 of 2
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride powder, for solution
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 250 mg in 250 mg
Packaging
# Item Code Package Description
1 250 mg in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/30/2019
Part 2 of 2
MICONAZOLE NITRATE
miconazole nitrate solution
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 200 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
RIBOPRINE
ACETIC ACID
WATER
BENZYL ALCOHOL
DIMETHYL SULFOXIDE
LAURETH-4
POLYETHYLENE GLYCOL 300
TEA TREE OIL
Packaging
# Item Code Package Description
1 10 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/30/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/30/2019
Labeler - Medhart Pharmaceuticals, Inc. (080145788)
Medhart Pharmaceuticals, Inc.