RE Benzotic Otic Drops

Benzocaine, a local anesthetic, is chemically, ethyl p-aminobenzoate, C9H11NO2, with a molecular weight of 165.19.

KEEP OUT OF REACH OF CHILDREN. NOT FOR OPHTHALMIC OR ORAL USE.
Use of anesthetic ear drops indiscriminately may mask symptoms of infection of the middle ear.

General: Medication should be discontinued if sensitivity or irritation occurs.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies of animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should only be given to pregnant women if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Caution should be used when administered to nursing women.

Pediatric Use: Do not use in infants under 1 year of age.

Effects of benzocaine overdosage may include yawning, restlessness, excitement, nausea and vomiting. Treatment is symptomatic. Please call your local Poison Control Center or your doctor if you suspect an overdosage of this product.

Administer 4-5 drops of RE Benzotic Otic Drops in the external ear canal and then insert a cotton pledget into the meatus. Can be repeated every 1 to 2 hours, if necessary.

RE Benzotic Otic Drops are supplied as a pale yellow liquid in a 15 mL vial, NDC 68032-378-15, and include a wrapped dropper.