FDA label 17727159-0bd7-4fa0-8240-d6463cbfd0aa

Warning: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS OF LIDOCAINE AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Warnings: For external use only Do not use: - on wounds or damaged skin -with a heating pad - on a child under 12 years of age with arthritis-like conditions Ask a doctor before use if you have redness over the affected area When using this product: - avoid contact with eyes or mucous membranes - do not bandage tightly Stop use and ask a doctor if: - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation occurs Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately

WARNINGS AND PRECAUTIONS For External Use Only. Avoid Contact with Eyes. If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. LDO Plus should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP.

5. Warnings and Precautions: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. LDO Plus should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP. In case of accidental ingestion get medical help or contact poison control center right away.

ADVERSE REACTIONS Most common adverse reactions are redness or swelling at the application site. Less common side effects, such as sluggishness, confusion, slow breathing, low blood pressure, or slow heartbeat, may occur. To report SUSPECTED ADVERSE REACTIONS, contact Gensco Pharma at 866-608-6284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6. Adverse Reactions: Adverse experiences following the administration of Lidocaine Hydrochloride USP are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: 6.1 Central nervous system: CNS manifestations of Lidocaine toxicity are excitatory and/or depressant and may be characterized by lightheadedness, 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. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of Lidocaine Hydrochloride USP is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. 6.2 Cardiovascular system: Cardiovascular manifestations of Lidocaine toxicity are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. 6.3 Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. Allergic reactions as a result of sensitivity to Lidocaine Hydrochloride USP are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.