NDC 0338-0656 Acetic Acid
Irrigant Irrigation

Product Information

Acetic Acid is a human prescription drug product labeled by Baxter Healthcare Corporation. The product's dosage form is irrigant and is administered via irrigation form.

Product Code0338-0656
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 FormIrrigant - A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Irrigation - Administration to bathe or flush open wounds or body cavities.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Baxter Healthcare Corporation
Labeler Code0338
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.
NDA018523
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.
NDA - A product marketed under an approved 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.
02-19-1982
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.
12-31-2023
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 0338-0656-04

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

Price per Unit: $0.00302 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 250 mg/100mL - 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.
  • WATER (UNII: 059QF0KO0R)

* 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



0.25% Acetic Acid Irrigation, USP, is a sterile, nonpyrogenic hypotonic solution for irrigation of the urinary bladder. Each 100 mL contains 250 mg Glacial Acetic Acid, USP, (CH3COOH) in Water for Injection, USP. pH 3.0 (2.8 to 3.4). Osmolarity: 42 mOsmol/L (calc.). No antimicrobial agent has been added.

The container is made from specially formulated polyolefin (PL 325). The polyolefin is a copolymer of ethylene and propylene. It contains no plasticizers or other mobile additives. As a result, the container has virtually no extractability or leachability. The total extractables after two years of storage being less than 0.01 ppm. It is also relatively impermeable to water vapor transmission and, therefore, requires no vapor barrier to maintain the proper drug concentration.


Clinical Pharmacology



The minimal amount of acetic acid which may enter the systemic circulation is readily metabolized.


Indications And Usage



0.25% Acetic Acid Irrigation, USP, is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. It also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations.


Contraindications



None known


Warnings



Not for injection.

Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesion. Absorption via open lesions of the bladder mucosa may result in systemic acidosis.

The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.


Other



Animal reproduction studies have not been conducted with 0.25% Acetic Acid Irrigation, USP. It is also not known whether 0.25% Acetic Acid Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation, USP should be given to a pregnant woman only if clearly needed.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

Baxter is a registered trademark of Baxter International Inc.

07-19-00-0228

Rev. February 2018


Pediatric Use



Safety and effectiveness in pediatric patients have not been established.

Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming.

Do not administer unless the solution is clear and the seal is intact.


Adverse Reactions



Systemic acidosis, pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% Acetic Acid Irrigation, USP.

Should adverse reactions occur, discontinue the irrigation and reevaluate the clinical status of the patient.


Dosage And Administration



The volume of solution needed will vary with nature and duration of the urologic procedure, according to physician’s instructions.

Irrigation drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.


How Supplied



0.25% Acetic Acid Irrigation, USP is supplied in a plastic pour bottle as follows:

2F7184

1000 mL

NDC 0338-0656-04

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.


Package Label - Principal Display Panel



Container Label

Not for Injection 2F7184
NDC 0338-0656-04

0.25% Acetic Acid
Irrigation, USP

1000 mL

Each 100 mL contains: 250 mg Glacial Acetic Acid,
USP. No antimicrobial agent has been added.
pH 3.0 (2.8 to 3.4). Osmolarity 42 mOsmol/L
(calc.). Sterile, nonpyrogenic. Pour Bottle.
Hypotonic solution for irrigation only. Dosage and
Administration: As directed by a physician. See
directions. Cautions: Warm in oven to not more than
50°C for a maximum of 60 days. Discard after 60
days of warming. Do not use unless solution is clear
and seal is intact. Discard unused portion. Rx only.
Recommended storage: Room temperature (25°C).
Avoid excessive heat. See insert.

PL 325 plastic

Baxter Logo
Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Made in USA

07-09-74-482

LOT
EXP

Bar Code Posit ion Only*
(01) 00303380656042

Carton Label

0.25% Acetic Acid
Irrigation, USP
Pour Bottle

1000 ML

NDC 0338-0656-04 2F7184

EXP JUN 08 LOT# G012345

Qty 12

(01)50303380656047 (17)080630(10)G012345


* Please review the disclaimer below.