RE Benzotic Otic Drops

Generic name: benzocaine
Dosage form: otic liquid
Drug class:Otic anesthetics

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

INGREDIENTS:

ACTIVE INGREDIENT:
Benzocaine.....20% in an aqueous base.

INACTIVE INGREDIENTS:
Glycerin, Polyethylene Glycol, Benzethonium Chloride, Purified Water.

DESCRIPTION:

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

CLINICAL PHARMACOLOGY:

Benzocaine acts by blocking conduction in nerve fibers as a result of decreased nerve cell membrane permeability to sodium ions or competition with calcium ions for membrane binding sites.

INDICATIONS AND USAGE:

RE Benzotic Otic Drops may be used as a topical anesthetic in the external auditory canal to relieve ear pain. It may be used in the treatment of acute otitis media, acute swimmer’s ear and other forms of otitis externa.

CONTRAINDICATIONS:

RE Benzotic Otic Drops is contraindicated in patients sensitive to benzocaine. This medication should not be applied in the external auditory canal if there is a perforated eardrum or ear discharge.

WARNINGS:

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.

PRECAUTIONS:

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.
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