DESCRIPTION SECTION.

DESCRIPTION. Acetic Acid Otic Solution USP is nonaqueous solution of glacial acetic acid, USP (2%), in propylene glycol vehicle containing benzethonium chloride, USP (0.02%); propylene glycol diacetate, NF (3%) and sodium acetate, USP (0.015%). It may also contain citric acid, USP.The molecular formula for acetic acid is CH 3COOH, with molecular weight of 60.05. The structural formula is: Acetic Acid Otic Solution is available as nonaqueous otic solution buffered at pH for use in the external ear canal.. structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Carefully remove all cerumen and debris to allow Acetic Acid 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 of Acetic Acid Otic Solution 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Acetic Acid Otic Solution USP, 2% is available in 15 mL (NDC 64980-424-15) measured-drop, safety- tip plastic bottles.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 15 mL bottle. Rising (R) NDC 64980-424-15Acetic Acid OticSolution USP, 2% DO NOT USE IF BAND PRINTED SEALED FOR YOUR PROTECTION AROUND CAP IS BROKEN OR MISSING. 15 mLR only bottle.

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.

STORAGE. Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.]KEEP CONTAINER TIGHTLY CLOSEDRx OnlyDistributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 MADE IN USARev. 12/2018.

WARNINGS SECTION.

WARNINGS. Discontinue promptly if sensitization or irritation occurs.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Hypersensitivity to Acetic Acid Otic Solution or any of the ingredients. Perforated tympanic membrane is considered contraindication to the use of any medication in the external ear canal.

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 anti-fungal; propylene glycol is hydrophilic and provides low surface tension; benzethonium chloride is surface active agent that promotes contact of the solution with tissues.