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:

Rising Pharmaceuticals, Inc.

INN (International Name):

ACETIC ACID

Composition:

ACETIC ACID 20.65 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 available in 15 mL (NDC 64980-424-15) measured-drop, safety- tip plastic bottles.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETIC ACID - ACETIC ACID SOLUTION
RISING 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.
3
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 addi