NDC 0338-0004 Sterile Water

Water

NDC Product Code 0338-0004

NDC 0338-0004-02

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

NDC 0338-0004-03

Package Description: 18 BOTTLE, PLASTIC in 1 CARTON > 500 mL in 1 BOTTLE, PLASTIC

NDC 0338-0004-04

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

NDC 0338-0004-05

Package Description: 9 BOTTLE, PLASTIC in 1 CARTON > 1500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Sterile Water with NDC 0338-0004 is a a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Sterile Water is water. The product's dosage form is irrigant and is administered via irrigation form.

Labeler Name: Baxter Healthcare Corporation

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.

Sterile Water 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.

  • WATER 100 mL/100mL

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.

Labeler Name: Baxter Healthcare Corporation
Labeler Code: 0338
FDA Application Number: NDA017428 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: 12-31-1974 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 - NO 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".

* Please review the disclaimer below.

Sterile Water 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

1 Indications And Usage

Sterile Water for Irrigation is indicated for use as an irrigant.

2.1 Important Administration Instructions

  • •For irrigation only. Not for intravenous injection. •Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. It is intended for use as an irrigation fluid and not for intravenous administration or administration by other, parenteral routes (e.g., subcutaneous or intramuscular) [see Warnings and Precautions (5.1)]. •Sterile Water for Irrigation is not potable water and is not intended for oral administration. •Sterile Water for Irrigation that has been warmed must not be returned to storage.

The volume and/or rate of irrigation depend on the type of the procedure and the capacity or the surface area of the structure to be irrigated.

2.3 Preparation And Administration Instructions

  • For single-dose only. Sterile Water for Irrigation is available in a flexible plastic container and a plastic pour bottle. Use the contents of the opened container immediately to minimize the potential for bacterial growth and pyrogen formation. Discard the unused contents of opened containers, as Sterile Water for Irrigation contains no antimicrobial preservative.Adding Medications to Either the Flexible Plastic Container or the Plastic Pour Bottle •Use aseptic technique when making additions to Sterile Water for Irrigation. •Additives may be incompatible with Sterile Water for Irrigation. •The compatibility of additives with Sterile Water for Irrigation must be assessed. Before introducing additives, check for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. •Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sterile Water for Irrigation is appropriate. •Additives known or determined to be incompatible should not be used. •Mix thoroughly after additives have been introduced. •Use immediately.Administration Instructions for Irrigation by Gravity Using the Flexible Plastic Container1.Use aseptic technique. 2.Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired. 3.Suspend container using hanger hole.4.Remove plastic protector from outlet port at bottom of container.5.Attach irrigation set. Refer to complete directions accompanying set.WarmingIf desired, warm the flexible plastic container in overwrap to near body temperature in a water bath or fluid warmer heated to not more than 45°C. Microwave heating of irrigation fluids is not recommended.Administration Using the Plastic Pour Bottle1.Inspect Sterile Water for Irrigation visually for particulate matter and discoloration prior to use. Discard if the fluid is not clear or the seal is broken. 2.Use aseptic technique 3.Remove the plastic shrink band by tearing along the perforation line and unscrew the bottle cap.4.Prevent contact of the fluid with the external surface of the container (including the thread for the bottle cap of the plastic pour bottle).WarmingIf desired, warm the plastic pour bottle in a fluid warmer to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Microwave heating of irrigation fluids is not recommended.

3 Dosage Forms And Strengths

  • Irrigation: •250, 500, 1000, and 1500 mL sterile water for irrigation in a single-dose plastic pour bottle •1000, 2000 and 3000 mL sterile water for irrigation in a single-dose flexible plastic container

4 Contraindications

None.

5.1 Hypotonicity

Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. It is intended for use as irrigation fluid and not for intravenous administration or administration by other, usual parenteral routes, such as intravascular administration in general, subcutaneous administration, or intramuscular administration.Serious adverse reactions, including cerebral or pulmonary edema, massive hemolysis, and acute renal failure can result from the hypotonicity of Sterile Water for Irrigation [see Warnings and Precautions (5.2)].

5.2 Excessive Water Absorption

  • Due to the hypotonicity, absorption of Sterile Water for Irrigation can result in serious adverse reactions of hyponatremia, hypoosmolality and fluid overload, resulting in fatality or permanent morbidity. Complications include cerebral edema, encephalopathy, pulmonary edema, massive hemolysis, rhabdomyolysis, renal failure, and hyperkalemia [see Adverse Reactions (6)]. In addition, excessive volume or pressure of the irrigation fluid may also cause undue distension of body cavities and may cause tissue disruption (e.g., tears or perforation). These complications can manifest after irrigation has ended and immediate intervention may be required. Monitor patients closely for absorption of clinically relevant amounts of fluid during and for an appropriate period after the procedure. If absorption occurs, discontinue Sterile Water for Irrigation. Additional close monitoring during and/or after the procedure is recommended for patients at increased risk for developing complications related to hypotonicity, such as: •fluid overload syndrome, including patients with severe renal impairment, impaired cardiac function, or other clinical conditions associated with edematous states. •hyponatremic encephalopathy, including pediatric patients; women, in particular premenopausal women; patients with hypoxemia; and patients with underlying central nervous system disease.Avoid use of Sterile Water for Irrigation in patients with wounds where significant absorption may occur, such as procedures that require irrigation over a longer period of time or an irrigation fluid pressure that promotes absorption (e.g., transurethral resection of prostate). Sterile Water for Irrigation should only be used by clinicians familiar with the treatment of possible complications.

5.3 Use With Electrosurgery/Cautery

In contrast to other irrigation fluids containing electrolytes, Sterile Water for Irrigation is non-conductive. Therefore, when choosing the distension solution/fluid used with electrosurgery or cautery, ensure compatibility with the equipment.

6 Adverse Reactions

The following adverse reactions have been identified during post approval use of Sterile Water for Irrigation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Metabolism and Nutrition disorders: Hyponatremia, fluid overload, fluid absorption, electrolyte imbalanceNervous System Disorders: Cerebral edemaGeneral Disorders and Administration Site Conditions: Burning sensation (with irrigation of eyes and skin wounds)Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis (myoglobinuria)Renal and Urinary Disorders: Renal failureOther Adverse reactions which may occur in association with absorption of water for irrigation include:Blood and Lymphatic System Disorders: Hemolysis (hemoglobinemia, hemoglobinuria)Metabolism and Nutrition Disorders: Hypervolemia, hypoosmolality, hyperkalemia, acid/base balance disorderNervous System Disorders: Encephalopathy (seizure, loss of vision, lethargy, disorientation, irritability, vomiting, nausea, headache)Cardiac Disorders: Cardiac arrest, cardiac failure, bradycardia, electrocardiogram abnormalVascular Disorders: Hypertension, postoperative hypotensionRespiratory, Thoracic and Mediastinal Disorders: Respiratory arrest, respiratory failure, pulmonary edema

8.1 Pregnancy

Risk SummaryAppropriate administration of Sterile Water for Irrigation is not expected to cause adverse developmental outcomes. There are no available data on Sterile Water for Irrigation use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Sterile Water for Irrigation. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

8.2 Lactation

Risk SummaryAppropriate administration of Sterile Water for Irrigation is not expected to cause harm to a breastfed infant. There are no data on the presence of Sterile Water for Irrigation in either human or animal milk, the effects on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Sterile Water for Irrigation to a breastfed infant; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sterile Water for Irrigation and any potential adverse effects on the breastfed infant from Sterile Water for Irrigation or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Pediatric patients are at higher risk compared to adults for developing encephalopathy as a complication of hyponatremia, if there is excessive absorption of Sterile Water for Irrigation [see Warnings and Precautions (5.2)].

8.5 Geriatric Use

Sterile Water for Irrigation should be used cautiously in older patients. Geriatric patients are more likely to have decreased cardiac, renal, or hepatic function, and other diseases or concomitant drug therapy.

10 Overdosage

Excessive rate, volume, pressure or duration of irrigation with hypotonic fluid can result in excessive fluid absorption and permanent morbidity or death as a result of hyponatremia, hypoosmolality and/or fluid overload. In the event of clinically relevant absorption of Sterile Water for Irrigation, immediate intervention may be required [see Warnings and Precautions (5.2)].

11 Description

Sterile Water for Irrigation contains water that is sterilized and packaged for use as an irrigant. No antimicrobial agent or other substance has been added. The pH is 5.5 (5.0 to 7.0). Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the fluid significantly. Water 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.The plastic pour bottle is fabricated from specially formulated polyolefin. The polyolefin is a copolymer of ethylene and propylene. The container requires no vapor barrier.

16 How Supplied/Storage And Handling

  • Sterile Water for Irrigation is supplied in single-dose plastic pour bottles and flexible plastic containers as follows: ContainerProduct CodesFill Volume (mL)NDCPlastic Pour Bottle2F71122500338-0004-022F71135000338-0004-032F711410000338-0004-042F711515000338-0004-05Flexible Plastic Container2B711410000338-0003-442B711620000338-0003-462B711730000338-0003-47StorageExposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.

17 Patient Counseling Information

  • Inform patients, caregivers, or home healthcare providers of the following risks of Sterile Water for Irrigation: •Hypotonicity [see Warnings and Precautions (5.1)] •Excessive Water Absorption [see Warnings and Precautions (5.2)]

Other

Baxter Healthcare CorporationDeerfield, IL 60015 USAPrinted in USA07-19-77-916Baxter is a registered trademark of Baxter International Inc.

* Please review the disclaimer below.