OraPharma offers a comprehensive suite of products to address a range of patient concerns—from the foundation of gums, bone, and teeth, to cold sore medication.

ARESTIN INDICATION & IMPORTANT SAFETY INFORMATION

INDICATIONARESTIN® (minocycline HCl) Microspheres, 1mg is indicated as an adjunct to scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis.  ARESTIN® may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP.

    IMPORTANT SAFETY INFORMATION
  • ARESTIN is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines.  Hypersensitivity reactions and hypersensitivity syndrome that included, but were not limited to anaphylaxis, anaphylactoid reaction, angioneurotic edema, urticaria, rash, eosinophilia, and one or more of the following:  hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis may be present.  Swelling of the face, pruritus, fever and lymphadenopathy have been reported with the use of ARESTIN.  Some of these reactions were serious.  Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with oral minocycline, as well as acute photosensitivity reactions.
  • THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.
  • Tetracyclines, including oral minocycline, have been associated with development of autoimmune syndromes including a lupus-like syndrome manifested by arthralgia, myalgia, rash, and swelling.  Sporadic cases of serum sickness-like reaction have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, lymphadenopathy and malaise.  In symptomatic patients, diagnostic tests should be performed and ARESTIN treatment discontinued.
  • The use of ARESTIN in an acutely abscessed periodontal pocket or for use in the regeneration of alveolar bone has not been studied.
  • The safety and effectiveness of ARESTIN has not been established in immunocompromised patients or in those with coexistent oral candidiasis.  Use with caution if there is a predisposition to oral candidiasis.
  • In clinical trials, the most frequently reported nondental treatment-emergent adverse events were headache, infection, flu syndrome, and pain.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information.

NEUTRASAL® INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONSNeutraSal® is indicated for dryness of the mouth (hyposalivation, xerostomia) and dryness of the oral mucosa due to drugs that suppress salivary secretion.

    IMPORTANT SAFETY INFORMATION
  • Not intended to prevent xerostomia or oral mucositis.
  • Patients should avoid eating or drinking for at least 15 minutes after use
  • Solution should not be swallowed but be spit out.
  • Not intended for systemic use to treat any diseases of the throat or upper gastrointestinal tract
  • Not intended for use as an antacid
  • No adverse events anticipated if swallowed accidentally
  • Contains sodium; consult with patients on a low sodium diet
  • No known interactions with medicinal or other products

Please click here for Instructions for Use.

INDICATION FOR OSSIX® Bone | BONE GRAFTING MATERIALOSSIX® Bone is a sterile, biocompatible bone grafting material aimed to fill, augment, or reconstruct periodontal and bony defects of the maxillo-facial complex.

    IMPORTANT SAFETY INFORMATION FOR OSSIX® Bone
  • OSSIX® Bone must not be used in:
    • Patients with known collagen hypersensitivity.
    • Patients with a sensitivity to porcine-derived materials.
    • Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
    • Patients with acute or chronic infection (osteomyelitis) at the surgical site.
    • Patients with vascular impairment at the implant site.
    • Patients with uncontrolled periodontal disease.
    • Patients that have received or are currently receiving treatment with bisphosphonates.
    • OSSIX® Bone should not be used in the presence of infected wounds at the site of implantation.
  • OSSIX® Bone is intended for a single use only.  Do not re-sterilize or reuse.
  • As OSSIX® Bone contains collagen, allergic reactions (e.g. erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

Click here for Instructions for Use.

INDICATION FOR OSSIX Plus® AND OSSIX® Volumax | RESORBABLE COLLAGEN MEMBRANESOSSIX PLUS® and OSSIX® VOLUMAX biodegradable collagen membranes are intended for use during the process of guided tissue regeneration (GTR) and guided bone regeneration (GBR) as a biodegradable barrier.

    IMPORTANT SAFETY INFORMATION FOR OSSIX Plus® AND OSSIX® Volumax
  • OSSIX PLUS® and OSSIX® VOLUMAX must not be used in:
    • Patients with known collagen hypersensitivity
    • Patients with a sensitivity to porcine-derived materials
    • Patients suffering from autoimmune disease and connective tissue disease, such as systemic lupus erythematosus, dermatomyositis, etc.
  • OSSIX PLUS® and OSSIX® VOLUMAX are intended for use as a single use device.  Do not resterilize.
  • Treatment of high risk patients, such as smokers and patients with uncontrolled diabetes or periodontal disease, may be impaired.  Infection control and good oral hygiene should be achieved prior to surgical intervention.
  • Clinical and post marketing experience with OSSIX PLUS® reveals an excellent safety profile.  Adverse reactions with OSSIX PLUS® were not observed.  Yet, as the membrane is of a collagen origin, allergic reactions (e.g., erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

Click here for Instructions for Use.

INDICATION FOR OSSIX® Graft | PARTICULATE ALLOGRAFT

OSSIX® GRAFT Particulate Allograft products consist of cortical bone matrix and may be used in a variety of reconstructive, periodontal, and oral maxillofacial procedures.  OSSIX® GRAFT contains Human Cellular and Tissue Based Product (HCT/P).

    IMPORTANT SAFETY INFORMATION FOR OSSIX® Graft
  • OSSIX® GRAFT is contraindicated in:
    • Active or latent infection at the surgical implantation site.
    • Sensitivity or allergies to any of the processing agents listed under the Processing section of the Instructions for Use.  Processing agents may include some or all of the following:  Bacitracin, Polymyxin B Sulfate, Gentamicin, Allowash, alcohol and/or hydrogen peroxide.
    • Use in immunocompromised patients.
  • As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted.
  • Single patient, single use only.  Do not sterilize or re-sterilize.
  • Do not use if the packaging or labeling is damaged or has flaws.  Do not use if the expiration date has been exceeded.
  • Recommended storage conditions and the maintenance of the tissue for transplantation are the responsibility of the hospital or clinician.  Do not use if tissue has not been stored according to the recommended storage instructions.
  • Prior to clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the product.
  • Antibiotic acceptability must be discussed with the patient to discern patient status regarding antibiotic sensitivity.
  • Use standard practices for handling and disposal of human tissue.
  • Inherent uncertainty exists in medical and social histories and lab testing which may not detect known or unknown pathogens.  Therefore, the following complications may occur with tissue transplantation:
    • Transmission of diseases of unknown etiology;
    • Bacterial or fungal infection;
    • Immune rejection of implanted HCT/P; or
    • Loss of function and/or integrity of implanted HCT/P due to resorption, fragmentation, and/or disintegration.
  • Maintain documentation about the disposition of each tissue to enable tracking from the donor to the consignee or final disposition.  Complete and submit the Allograft Tracing Record (ATR) using preprinted labels included with every graft.
    • Although efforts have been made to ensure the safety of allograft material, current technologies may not preclude the transmission of disease.  Adverse outcomes potentially attributable to the tissue or unanticipated or adverse events must be reported immediately to your distributor.  USA: 1-800-321-4576.

Click here for Instructions for Use.

XERESE INDICATION & IMPORTANT SAFETY INFORMATION

INDICATIONXERESE® (acyclovir and hydrocortisone) cream 5%/1% is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in patients 6 years of age and older.

    IMPORTANT SAFETY INFORMATION
  • XERESE (acyclovir and hydrocortisone) cream 5%/1% is intended for cutaneous use only, on the lips and around the mouth.  XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.
  • Systemic exposure to acyclovir and hydrocortisone following topical administration is minimal.  However, caution should be exercised when XERESE is administered to women who are pregnant or nursing.  The benefit of XERESE has not been adequately assessed in immunocompromised patients.
  • XERESE has a potential for irritation and contact sensitization.
  • In clinical trials, the most common adverse reactions in the area of the application site included drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation.  Each event occurred in less than 1% of patients.
  • Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information.