Acetic Acid

ACETIC ACID — acetic acid solution
Rising Pharmaceuticals, Inc.

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 CH3 COOH, with a molecular weight of 60.05. The structural formula is:

structure

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

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

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

KEEP CONTAINER TIGHTLY CLOSED

Rx Only

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

Distributed by:
Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663

Rev. 05/2018

PRINCIPAL DISPLAY PANEL — 15 mL bottle

Rising®

NDC 64980-424-15

Acetic Acid Otic

Solution USP, 2%

DO NOT USE IF BAND PRINTED
“SEALED FOR YOUR PROTECTION”
AROUND CAP IS BROKEN OR MISSING.

15 mL

Rx only

bottle
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mL Carton

Rising®

NDC 64980-424-15

Acetic Acid

Otic Solution

USP, 2%

DO NOT USE IF BAND

PRINTED “SEALED FOR

YOUR PROTECTION”

AROUND CAP IS BROKEN

OR MISSING”

15mL

Rx only

carton
(click image for full-size original)

carton
ACETIC ACID
acetic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-424
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETIC ACID (ACETIC ACID) ACETIC ACID 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL DIACETATE
BENZETHONIUM CHLORIDE
SODIUM ACETATE
ANHYDROUS CITRIC ACID
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-424-15 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (64980-424-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207280 03/14/2018
Labeler — Rising Pharmaceuticals, Inc. (041241766)

Revised: 06/2018 Rising Pharmaceuticals, Inc.

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