Prescription Drugs

CLINICAL PHARMACOLOGYBenzocaine 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.

PATIENT INFORMATIONPlease refer to the PRECAUTIONS section.

OVERDOSE No information is available. CONTRAINDICATIONS Known allergy or hypersensitivity to benzocaine.

SIDE EFFECTSContact 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. DRUG INTERACTIONS No information is available.

WARNINGSNo information is available. PRECAUTIONSGeneral: 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 (benzocaine) Anesthetic Lubricant. It is also not known whether AMERICAINE (benzocaine) Anesthetic Lubricant can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AMERICAINE (benzocaine) 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 (benzocaine) Anesthetic Lubricant is administered to a nursing woman. Pediatric Use: Do not use in infants under 1 year of age.