Acetic Acid
FDA Label NDC 50436-4600

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unit Dose Services for the product Acetic Acid (NDC 50436-4600). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, pediatric use, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Acetic Acid Otic Solution, USP is a nonaqueous solution of glacial acetic acid, USP (2%), in a 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 CH3COOH, with a molecular weight of 60.05. The structural formula is:

Acetic-01 (9ba18bd7 Ca92 4509 83f7 9a29e336686c 01)

Acetic-01 (9ba18bd7 Ca92 4509 83f7 9a29e336686c 01)

Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

Clinical Pharmacology

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

Indications And Usage

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

Contraindications

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

Warnings

Discontinue promptly if sensitization or irritation occurs.

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 3 years have not been established.

Adverse Reactions

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

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 a 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 3 to 5 drops of the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Acetic Acid Otic Solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.

How Supplied

Product: 50436-4600

NDC: 50436-4600-1 15 mL in a BOTTLE

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