NDC 71150-786 Onycho-med

Miconazole Nitrate, Terbinafine Hcl

NDC Product Code 71150-786

NDC 71150-786-10

Package Description: 1 KIT in 1 BOX * 250 mg in 1 BOTTLE, GLASS * 10 mL in 1 BOTTLE, GLASS

NDC Product Information

Onycho-med with NDC 71150-786 is a a human prescription drug product labeled by Medhart Pharmaceuticals, Inc.. The generic name of Onycho-med is miconazole nitrate, terbinafine hcl. The product's dosage form is kit and is administered via topical form.

Labeler Name: Medhart Pharmaceuticals, Inc.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

* Please review the disclaimer below.

Onycho-med Product Label Images

Onycho-med Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 onychomycosisMixing Instructions - Easy Two Step ProcessPlease check expiration dates listed on the bottlesInspect product integrity seals on the bottles inside the cartonTake the bottles out of the carton and set aside the carton, as illustrated in the picture to the leftOpen the black brush-cap on the Miconazole Nitrate 2% bottle and place it aside for re-useCarefully un-screw the white cap from the Terbinafine Hcl 250mg bottle and set aside to discard laterCarefully pour the contents of the bottle labelled Miconazole Nitrate USP 2% into the bottle labelled Terbinafine Hcl powder 250mgPlace 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-capNow shake the bottle containing Terbinafine Hcl 250mg USP powder and Miconazole Nitrate USP 2% solution vigorously for 30 secondsMake sure the contents have dissolved and there is no residueApply the pharmacy label to the bottle with final solutionPlace the final solution (bottle with black brush cap) back into the cartonDiscard the empty bottle of Miconazole Nitrate 2% and the white cap appropriatelyPlease 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 fileUsers are encouraged to report adverse events to FDA MedWatch1-800-FDA-1088 or at http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htmRX OnlyRevised: April2019Dear professionals we always value your feedback, please email at: suggestions@medhartpharma.comManufactured for:Medhart Pharmaceuticals, Inc.50 Eagle Rock Way, Suite C, Brentwood Ca 94513 Ph: 1-833-MEDHART (633-4278)

* Please review the disclaimer below.

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