Sodium Chloride

Package Insert

PIC™ (Plastic Irrigation Container)

0.9% Sodium Chloride Irrigation USP

Isotonic Solution for Irrigation.

For Irrigation Only.

Not for Injection.

Rx only

Each 100 mL contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF
pH: 5.0 (4.5–7.0)      Calculated Osmolarity: 310 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154

0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

Not made with natural rubber latex, PVC or DEHP.

Bottle may exhibit some discoloration upon storage which does not impact product quality.

0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection USP (normal saline).

Physiological irrigation solutions are considered generally compatible with living tissues and organs.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Do not warm above 150°F (66°C).

After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

In the event of overhydration or solute overload, reevaluate the patient’s condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

As required for irrigation.

When used as a diluent, or vehicle for other drugs, the drug manufacturer’s recommendations should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL and 500 mL containers are packaged 16 per case.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

Bottle may exhibit some discoloration upon storage which does not impact product quality.

Revised: June 2025

PIC is a trademark of B. Braun Medical Inc.

Not for injection.

Aseptic technique is required.

1. Caution – Before use, perform the following checks:
   
   (a)  Read the label. Ensure solution is the one ordered and is within the expiration date.
   
   (b)  Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the
          container for leakage or damage. Any container which is suspect should not be used.
   
   Use only if solution is clear and container and seal are intact.
   
   

   Bottle may exhibit some discoloration upon storage which does not impact product quality.

   
   Single-dose container. Discard unused portion.
   
   
2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off. (Figure 1)
   Figure 1
3. Connect the administration set through the sterile set port according to set instructions (Figure 2) or remove screw cap and pour.
   Figure 2
4. Do not warm above 150°F (66°C) to assure minimal bottle distortion. Keep bottles upright.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-003-105   LD-769-2

0.9% Sodium Chloride Irrigation USP

Isotonic Solution for Irrigation

REF R5200-01
NDC 0264-2201-00

1000 mL
PIC™ Container

Rx only

Lot
Exp.

Each 100 mL contains:
Sodium Chloride USP 0.9 g
Water for Injection USP qs
pH adjusted with Hydrochloric
Acid NF

pH: 5.0 (4.5-7.0)
Calc. Osmolarity: 310 mOsmol/liter

Electrolytes (mEq/liter):
Sodium 154   Chloride 154

Sterile, nonpyrogenic. Single-dose container. Discard unused portion.

Not for Injection. Use only if solution is clear and container and seal are intact.

Warning: Do not warm above 150°F (66°C).

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing.

Dosage: See Prescribing Information.

Not made with natural rubber latex, PVC or DEHP.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y37-002-590   LD-770-1

0.9% Sodium Chloride Irrigation USP

0.9% Sodium Chloride Irrigation USP

Isotonic Solution for Irrigation

REF R5201-01
NDC 0264-2201-10

500 mL
PIC™ Container

Rx only

Lot
Exp.

Each 100 mL contains:
Sodium Chloride USP 0.9 g
Water for Injection USP qs
pH adjusted with Hydrochloric
Acid NF

pH: 5.0 (4.5-7.0)
Calc. Osmolarity: 310 mOsmol/liter

Electrolytes (mEq/liter):
Sodium 154   Chloride 154

Sterile, nonpyrogenic. Single-dose container. Discard unused portion.

Not for Injection. Use only if solution is clear and container and seal are intact.

Warning: Do not warm above 150°F (66°C).

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing.

Dosage: See Prescribing Information.

Not made with natural rubber latex, PVC or DEHP.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y37-002-591   LD-771-1

0.9% Sodium Chloride Irrigation USP