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
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
Acetic Acid, Aqua, Benzyl Alcohol, DMSO, Isopropyl alcohol 70%, Laureth-4, PEG-6, Tea Tree Oil
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%.
- 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.
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: firstname.lastname@example.orgManufactured for:Medhart Pharmaceuticals, Inc.50 Eagle Rock Way, Suite C, Brentwood Ca 94513 Ph: 1-833-MEDHART (633-4278)
* Please review the disclaimer below.