Label: ONYCHO-MED- miconazole nitrate, terbinafine hcl kit

  • NDC Code(s): 71150-786-10
  • Packager: Medhart Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated April 19, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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:

    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

    • 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”

    Shake

    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 Nail Solution

    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

  • INGREDIENTS AND APPEARANCE
    ONYCHO-MED 
    miconazole nitrate, terbinafine hcl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71150-786
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71150-786-101 in 1 BOX; Type 0: Not a Combination Product04/16/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, GLASS 250 mg
    Part 21 BOTTLE, GLASS 10 mL
    Part 1 of 2
    TERBINAFINE HYDROCHLORIDE 
    terbinafine hydrochloride powder, for solution
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE250 mg  in 250 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1250 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/16/2019
    Part 2 of 2
    MICONAZOLE NITRATE 
    miconazole nitrate solution
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/16/2019
    Labeler - Medhart Pharmaceuticals, Inc. (080145788)