NDC 0990-6143 Acetic Acid

Acetic Acid

NDC Product Code 0990-6143

NDC CODE: 0990-6143

Proprietary Name: Acetic Acid 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.

Non-Proprietary Name: Acetic Acid 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Acetic acid is used to treat an outer ear infection (external otitis). It works by stopping the growth of bacteria and fungus. Treating the infection reduces pain and swelling in the ear. Wetness in the ear canal can help bacteria and fungus to grow. This medication may also contain drying ingredients such as glycerin or alcohol. Drying of the ear canal helps to cure the infection.

NDC Code Structure

NDC 0990-6143-09

Package Description: 12 BOTTLE, PLASTIC in 1 CASE > 1000 mL in 1 BOTTLE, PLASTIC

NDC 0990-6143-22

Package Description: 24 BOTTLE, PLASTIC in 1 CASE > 250 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Acetic Acid with NDC 0990-6143 is a a human prescription drug product labeled by Icu Medical Inc.. The generic name of Acetic Acid is acetic acid. The product's dosage form is irrigant and is administered via irrigation form.

Labeler Name: Icu Medical Inc.

Dosage Form: Irrigant - A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.

Product Type: Human Prescription Drug 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.

Acetic Acid Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETIC ACID 250 mg/100mL

Inactive Ingredient(s)

About the 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)

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.
  • 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.

Labeler Name: Icu Medical Inc.
Labeler Code: 0990
FDA Application Number: NDA017656 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 11-25-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Acetic Acid Product Label Images

Acetic Acid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

0.25% Acetic Acid Irrigation, USP, is a sterile, nonpyrogenic aqueous solution of Glacial Acetic Acid, USP for irrigation of the urinary bladder by the transurethral route (NOT FOR TUR). Each 100 mL contains 250 mg of Glacial Acetic Acid, in water for injection.The solution is hypotonic, 42 mOsmol/liter (calc.), in relation to the extracellular fluid compartment of the body (280 mOsmol/liter) and has a pH of 3.1 (2.8 to 3.4).Other than the active ingredient, acetic acid, the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. When smaller volumes are required the unused portion should be discarded.The solution is a urinary bladder antimicrobial, acidifying irrigant.Glacial Acetic Acid, USP is chemically designated acetic acid (C2H4O2) a liquid miscible with water. It has the following structural formula:CH3COOHWater for Injection is chemically designated H2O.The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Clinical Pharmacology

Irrigation of the urinary bladder with acetic acid solution in a concentration of 0.25% has been shown to exert an antimicrobial action against a variety of microorganisms (especially ammonia-forming bacteria) that frequently gain access to the urinary bladder in patients who require prolonged indwelling urethral catheterization. Its antimicrobial action is dependent on administration via the indwelling catheter at a sufficient rate (continuous or intermittent) to maintain an effluent pH of at least 5.0. Maintenance of low pH of bladder urine also helps reduce formation of calcium encrustations in the indwelling catheter.

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

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.This solution is contraindicated for irrigation during transurethral surgical procedures.

Warnings

  • FOR IRRIGATION ONLY. NOT FOR INJECTION.Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesions. 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 it contains no preservative.Do not heat over 66°C (150°F).

Precautions

If pain or hematuria should occur during irrigation, it should be discontinued and the patient re-evaluated.Do not use unless solution is clear, seal is intact and container is undamaged. Discard unused portion.Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Acetic Acid Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.Nursing Mothers: Caution should be exercised when Acetic Acid Irrigation, USP is administered to a nursing woman.Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Acetic Acid Irrigation, USP. It is also not known whether Acetic Acid Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Acetic Acid Irrigation, USP should be given to a pregnant woman only if clearly needed.Pediatric Usage: The safety and effectiveness have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Adverse Reactions

Systemic acidosis has been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution. Urologic pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution.

Overdosage

Systemic absorption is unlikely unless there are open lesions of the bladder mucosa that have gone undetected. In such event, discontinue the irrigation, evaluate the patient for possible systemic acidosis, intravascular hemolysis and circulatory overload and institute appropriate countermeasures as indicated. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.Oral LD50 in mice: 5 g/kg.

Dosage And Administration

0.25% Acetic Acid Irrigation, USP may be administered by gravity drip via an administration set connected to an indwelling urethral catheter designed for continuous or intermittent two-way flow. A disposable dispensing set should be used. A bulb or piston syringe may be used for periodic irrigation of an indwelling catheter.For continuous or intermittent irrigation, the rate of administration will correspond roughly to the rate of urine flow and should be adjusted to maintain a urinary effluent pH of 4.5 to 5.0. Nitrazine or other pH paper may be used to monitor pH, preferably at least four times daily. Drip rate should be adjusted as necessary to maintain desired pH; increasing flow rate reduces pH value and vice versa. With continuous or intermittent irrigation, each patient will require a volume of approximately 500 to 1500 mL per 24 hours.For periodic irrigation of an indwelling catheter to maintain patency, about 50 mL is required for each irrigation and may be administered using a bulb or piston syringe for injection and aspiration as often as desired.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

How Supplied

0.25% Acetic Acid Irrigation, USP is supplied in single-dose irrigation containers as follows:ListContainerSize (mL)6143Semi-rigid250 & 1000Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: December, 2018EN-5788Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

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