NDC 60432-741 Acetic Acid
Solution Auricular (otic)

Product Information

Acetic Acid is a human prescription drug product labeled by Morton Grove Pharmaceuticals, Inc.. The product's dosage form is solution and is administered via auricular (otic) form.

Product Code60432-741
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Acetic Acid
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Acetic Acid
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Auricular (otic) - Administration to or by way of the ear.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Morton Grove Pharmaceuticals, Inc.
Labeler Code60432
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ANDA040166
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-26-1996
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Acetic Acid?


Product Packages

NDC 60432-741-15

Package Description: 15 mL in 1 BOTTLE, PLASTIC

Price per Unit: $1.40571 per ML

NDC 60432-741-16

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 15 mL in 1 BOTTLE, PLASTIC (60432-741-15)

Price per Unit: $1.30260 per ML

Product Details

What are Acetic Acid Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETIC ACID 20 mg/mL - Product of the oxidation of ethanol and of the destructive distillation of wood. It is used locally, occasionally internally, as a counterirritant and also as a reagent. (Stedman, 26th ed)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)
  • BENZETHONIUM CHLORIDE (UNII: PH41D05744)
  • SODIUM ACETATE (UNII: 4550K0SC9B)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

* Please review the disclaimer below.

Acetic Acid Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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 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 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


Principal Display Panel



MGP

NDC 60432-741-15

ACETIC ACID

OTIC

SOLUTION

USP, 2%

DO NOT USE IF BAND

PRINTED "SEALED FOR YOUR

PROTECTION" AROUND CAP

IS BROKEN OR MISSING.

Rx Only

NET CONTENTS:

15 mL


* Please review the disclaimer below.