Lidocaine Hydrochloride, Benzalkonium Chloride

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.

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.

WARNINGS: For external use only. Not for ophthalmic use. EXCESSIVE DOSING: Excessive dosing by applying Diabecin HR™ Cream to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine. With recommended dosing, the average peak blood concentration is about 0.13 mcg/ mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.

Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, Diabecin HR™ Cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. Diabecin HR™ Cream is only recommended for use on intact skin. External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over Diabecin HR™ Cream is not recommended as this has not been evaluated and may increase plasma lidocaine levels. Eye Exposure: The contact of Diabecin HR™ Cream with eyes, although not studied, should be avoided based on the f indings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

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.

Teratogenic Effects: Pregnancy Category B. Lidocaine has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. There are, however, no adequate and well- controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine should be used during pregnancy only if clearly needed. Labor and Delivery: Lidocaine has not been studied in labor and delivery. Lidocaine is not contraindicated in labor and delivery. Should lidocaine be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered. Nursing Mothers: Lidocaine has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk: plasma ratio of lidocaine is 0.4. Caution should be exercised when lidocaine is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Lidocaine has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk: plasma ratio of lidocaine is 0.4. Caution should be exercised when lidocaine is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.