Acetic Acid (Page 2 of 2)

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).

Revised: June 2023

PIC is a trademark of B. Braun Medical Inc.

Directions for Use of PIC™ (Plastic Irrigation Container)

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.
    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.
Figure 1Figure 2

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

Y36-002-964 LD-777-1

PRINCIPAL DISPLAY PANEL — 1000 mL Bag Label

0.25% Acetic Acid
Irrigation USP

REF R6600-01
NDC 0264-2304-00
1000 mL

PIC™ Container

Rx only

Each 100 mL contains:
Glacial Acetic Acid USP 0.25 g
Water for Injection USP qs

pH: 3.1 (2.8–3.4)
Calc. Osmolarity: 42 mOsmol/liter, hypotonic

Not for Injection or Transurethral Surgery: Use only if solution is clear and container and seal are intact.

Sterile, nonpyrogenic. Single-dose container.

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.

Rx only

Not made with natural rubber latex, PVC or DEHP.

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

Lot Exp.

Y37-002-526 LD-778-1

0.25% Acetic Acid Irrigation USP

Principal Display Panel -- 1000 mL Bag Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mL Bag Label

0.25% Acetic Acid Irrigation USP

REF R6601-01
NDC 0264-2304-10
500 mL

PIC™ Container

Rx only

Each 100 mL contains:
Glacial Acetic Acid USP 0.25 g
Water for Injection USP qs

pH: 3.1 (2.8–3.4)
Calc. Osmolarity: 42 mOsmol/liter, hypotonic

Not for Injection or Transurethral Surgery: Use only if solution is clear and container and seal are intact.

Sterile, nonpyrogenic. Single-dose container.

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.

Rx only

Not made with natural rubber latex, PVC or DEHP.

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

Lot Exp.

Y37-002-527 LD-779-1

0.25% Acetic Acid Irrigation USP

Principal Display Panel -- 500 mL Bag Label
(click image for full-size original)
ACETIC ACID acetic acid irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-2304
Route of Administration IRRIGATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETIC ACID (ACETIC ACID) ACETIC ACID 0.25 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0264-2304-00 16 CONTAINER in 1 CASE contains a CONTAINER
1 1000 mL in 1 CONTAINER This package is contained within the CASE (0264-2304-00)
2 NDC:0264-2304-10 16 CONTAINER in 1 CASE contains a CONTAINER
2 500 mL in 1 CONTAINER This package is contained within the CASE (0264-2304-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018161 08/06/1979
Labeler — B. Braun Medical Inc. (002397347)

Revised: 08/2023 B. Braun Medical Inc.

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