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AMERICAINE Anesthetic Lubricant contains benzocaine 20% with benzethonium chloride 0.1% as a preservative in a water soluble base of polyethylene glycol 300 and 3350.
Benzocaine, a local anesthetic, is chemically ethyl p -aminobenzoate, C 9 H 11 NO 2 , with a molecular weight of 165.19 and has the following structural formula:
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Benzocaine reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.
AMERICAINE Anesthetic Lubricant is indicated for general use as a lubricant and topical anesthetic on intratracheal catheters and pharyngeal and nasal airways to obtund the pharyngeal and tracheal reflexes; on nasogastric and endoscopic tubes; urinary catheters; laryngoscopes; proctoscopes; sigmoidoscopes and vaginal specula.
Known allergy or hypersensitivity to benzocaine.
General: Medication should be discontinued if sensitivity or irritation occurs.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with AMERICAINE Anesthetic Lubricant. It is also not known whether AMERICAINE Anesthetic Lubricant can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AMERICAINE Anesthetic Lubricant should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AMERICAINE Anesthetic Lubricant is administered to a nursing woman.
Pediatric Use: Do not use in infants under 1 year of age.
Contact dermatitis and/or hypersensitivity to benzocaine can cause burning, stinging, pruritus, tenderness, erythema, rash, urticaria and edema. Rarely, benzocaine may induce methemoglobinemia causing respiratory distress and cyanosis. Intravenous methylene blue is the specific therapy for this condition.
Apply evenly to exterior of tube or instrument prior to use.
AMERICAINE Anesthetic Lubricant (benzocaine) is available in:
NDC 53014-376-16 28 g tube
NDC 53014-376-62 2.5 g unit dose foil packs, 144 per carton
Store at 15°-25°C (59°-77°F).
Rx only
MEDEVA PHARMACEUTICALS
Medeva Pharmaceuticals, Inc.
Rochester, NY 14623 USA
®Ciba-Geigy Corporation
©1999, Medeva Pharmaceuticals, Inc.
Rev. 5/99
R238D