DIABECIN HR

Full Prescribing Information: Description: Diabecin HR™ Cream contains 41.2 mg of Lidocaine HCl per gram, and 1.3 mg of Benzalkonium Chloride per gram in a vehicle of Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Arnica Montana Flower Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Carbomer, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cyclopentasiloxane, Dimethicone, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Methylsilanol Mannuronate, Panthenol, PEG-100 Stearate, Peucedanum Ostruthium (Masterwort) Leaf Extract, Phenoxyethanol, Propylene Glycol, Retinyl Palmitate, Sodium Lauroyl Sarcosinate, Stearic Acid, Tetrahexyldecyl Ascorbate, Triethanolamine, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum, Zea Mays (Corn) Starch.

INDICATIONS: Diabecin HR™ Cream is indicated for the temporary relief of pain and itching associated with minor skin irritations. It combines the anesthetic properties of Lidocaine, and the antiseptic effects of Benzalkonium Chloride to provide effective care for damaged skin.

: Apply to the affected area of the heel two or three times daily or as directed by a licensed healthcare practitioner. Use under the direction of a licensed healthcare practitioner.

: Tuberculosis or fungal lesions of the skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Application Site Reactions Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. It is advisable to apply a small amount on the forearm prior to first use. If any of these effects persist or worsen, contact your physician or pharmacist immediately. Systemic absorption of this medication is expected to be minimal when used as directed. However, if serious side effects occur (e.g., rash, swelling, severe dizziness), discontinue use and consult your pharmacist or physician. This is not a complete list of all possible side effects. You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch. Allergic Reactions: Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Other Adverse Events: Due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. Systemic (Dose-Related) Reactions: Systemic adverse reactions following appropriate use of lidocaine is unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest. To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800- 272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Antiarrhythmic Drugs: Diabecin HR™ Cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Diabecin HR™ Cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.