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warnings
WARNINGS: KEEP OUT OF REACH OF CHILDREN. NOT FOR OPHTHALMIC OR ORAL USE. As with all drugs containing a sympathomimetic or anesthetic, systemic reactions may occur after local application. Phenylephrine may cause blanching of the skin. Allergic and idiosyncratic reactions to local anesthetics have been observed infrequently. Discontinue promptly if sensitization or irritation occurs. Cross-sensitivity reactions between the members of the caine group or local anesthetics have been reported. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more often in asthmatic than nonasthmatic people.
ADVERSE REACTIONS: Following its absorption, phenylephrine may produce a pressor response or cause restlessness, anxiety, nervousness, weakness, pallor, headache and dizziness. Absorption of benzocaine and antipyrine in the plasma may cause chills, nausea, vomiting, tinnitus and agranulocytosis. Such reactions are unlikely following application of Chlorphenylcaine Otic Drops on the external ear canal. Benzocaine can cause a hypersensitivity reaction consisting of rash, urticaria and edema. Individuals frequently exposed to ester-type local anesthetics can develop contact dermatitis characterized by erythema and pruritus. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.