Apicaine-X Polyethylene glycol 400, Polyethylene glycol 3350, Propylene glycol, Glycerin, Menthol LIDOCAINE LIDOCAINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 PROPYLENE GLYCOL GLYCERIN MENTHOL

INDICATION AND USAGE Apicaine-X is a topical anesthetic ointment contains 5% lidocaine used for • temporary relief of minor aches and pains associated with arthritis, • simple backache, strain, muscle soreness, stiffness, • rectal itch or ulcers (anal fissures, piles), • numbing gums in dentistry and • the relief of sore nipples in nursing mothers It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. It can be applied topically for production of anesthesia of accessible mucous membranes of the oropharynx.

INDICATION AND USAGE Apicaine-X is a topical anesthetic ointment contains 5% lidocaine used for • temporary relief of minor aches and pains associated with arthritis, • simple backache, strain, muscle soreness, stiffness, • rectal itch or ulcers (anal fissures, piles), • numbing gums in dentistry and • the relief of sore nipples in nursing mothers It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. It can be applied topically for production of anesthesia of accessible mucous membranes of the oropharynx.

: Always use Apicaine-X Ointment exactly as prescribed by your doctor. Otherwise, follow the instructions below. If you are not sure how to use this medicine, talk to your doctor or pharmacist. Directions: Clean area with mild soap and warm water. Rinse and dry thoroughly. Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor. Adult Dose: • A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride). • In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) loidocaine base. No more than one-third of a jar, approximately 17-20 g of ointment or 850-1000 mg lidocaine base should be administered in any one day. Dosage for children: • The maximum dose for children may be determined by the application of one of the standard pediatric drug formulas (e.g. Clark's rule). For example a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg when calculated according to Clark's rule. • In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2 mg/lb) of body weight. No more than 3 doses should be administered within 24 hours. Administration: • In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment. • For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa. • Nursing mothers Apply to the nipples using a small piece of lint or gauze, wash off immediately before the next feed

To report SUSPECTED ADVERSE REACTIONS, contact Medicap Laboratories LLC. at 1-800-494-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. • Adverse effects are very rare and dose-related, mostly 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. • The following types are those most commonly reported: Central nervous system - CNS manifestations are excitatory and/or depressant and may be characterized by light-headedness, drowsiness, nervousness, apprehension, euphoria, confusion, dizziness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. • Drowsiness is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. • Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. • An allergic reaction may occur (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

STORAGE AND HANDLING: Store at controlled room temperature 20° - 25° C (68° - 77° F). Do not permit to freeze.

QUESTIONS? Call us at 1-800-494-7449