ACETIC ACID solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)

Available from:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

ACETIC ACID

Composition:

ACETIC ACID 20 mg in 1 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Acetic Acid Otic Solution USP, 2% is supplied in 15 mL measured drop, safety-tip plastic bottles. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP CONTAINER TIGHTLY CLOSED Rx Only Product No.: 8741 Manufactured For: Wockhardt USA, LLC Parsippany, NJ 07054 Manufactured By: Morton Grove Pharmaceuticals, Inc Morton Grove, IL 60053 A50-8741-15 REV. 09-12

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETIC ACID- ACETIC ACID SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
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ACETIC ACID OTIC SOLUTION USP, 2%
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 CH COOH, with a molecular
weight of 60.05. The structural
formula is:
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.
3
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 b