Acetic Acid Irrigation

Name: Acetic Acid Irrigation

Acetic Acid Irrigation 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.

Contraindications

None known

Acetic Acid Irrigation 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 is Acetic Acid Irrigation 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 40ºC does not adversely affect the product.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-63-439

Rev. February 2010

Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

*BAR CODE POSITION ONLY
071963439

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

ACETIC ACID 
acetic acid irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0656
Route of Administration IRRIGATION DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETIC ACID (ACETIC ACID) ACETIC ACID 250 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0338-0656-04 1000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018523 02/19/1982
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 001728059 MANUFACTURE(0338-0656), ANALYSIS(0338-0656), PACK(0338-0656), LABEL(0338-0656), STERILIZE(0338-0656)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0656)
Revised: 04/2015   Baxter Healthcare Corporation

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

No monograph available at this time.

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

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