HOW SUPPLIED SECTION.

HOW SUPPLIED. Hydrocortisone 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle.10 mL bottleNDC 51672-3007-1. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 10 mL Bottle Carton. 10 mLNDC 51672-3007-1Hydrocortisone 1%and Acetic Acid 2%Otic Solution USPFOR OTIC USE ONLY.Keep this and allmedications out of thereach of children.Rx onlyTARO. PRINCIPAL DISPLAY PANEL 10 mL Bottle Carton.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness in pediatric patients below the age of years have not been established.

PRECAUTIONS SECTION.

PRECAUTIONS. Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.. Pediatric Use. Safety and effectiveness in pediatric patients below the age of years have not been established.

STORAGE AND HANDLING SECTION.

Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Acetic acid is anti-bacterial and antifungal; hydrocortisone is anti-inflammatory, antiallergic and antipruritic; propylene glycol is hydrophilic and provides low surface tension; benzethonium chloride is surface active agent that promotes contact of the solution with tissues.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Hypersensitivity to hydrocortisone and acetic acid otic solution or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered contraindication to the use of any medication in the external ear canal.

DESCRIPTION SECTION.

DESCRIPTION. Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.2%), propylene glycol diacetate (3%) and sodium acetate (0.015%).Acetic acid has molecular formula of CH3COOH with molecular weight of 60.05. The structural formula is:Acetic AcidHydrocortisone is Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11)-. Hydrocortisone has molecular formula of C21H30O5 with molecular weight 362.46. The structural formula is:HydrocortisoneHydrocortisone and acetic acid is available as non-aqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal.. Chemical Structure. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Carefully remove all cerumen and debris to allow hydrocortisone 1% and acetic acid 2% otic solution to contact infected surfaces directly. To promote continuous contact, insert wick of cotton saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding to drops of the solution every to hours. The wick may be removed after 24 hours but the patient should continue to instill drops or times daily thereafter, for as long as indicated. In pediatric patients, to drops may be sufficient due to the smaller capacity of the ear canal.