Balanced Salt Solution

Name: Balanced Salt Solution

What are some things I need to know or do while I take Balanced Salt Solution?

  • Tell all of your health care providers that you take balanced salt solution. This includes your doctors, nurses, pharmacists, and dentists.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

How do I store and/or throw out Balanced Salt Solution?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Clinical pharmacology

Balanced Salt Solution is an isotonic solution for use in irrigating tissues of the eyes.

Warnings

  • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
  • Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged.
  • Do not use if product is discolored or contains a precipitate.
  • SINGLE patient use only. The contents of this bottle should not be used in more than one patient.
  • This solution contains no preservative, unused contents should be discarded.

Dosage and administration

This irrigating solution should be used according to standard format for each surgical procedure.

Note: Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow directions of the particular administration set to be used. Remove the flip-off cap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bottle through the target area of the rubber stopper.

Allow the fluid to flow and remove air from the tubing before irrigation begins.

How supplied

Balanced Salt Solution ( Sterile Irrigating Solution) is supplied in a glass bottle using a grey butyl stopper and aluminum seal with a polypropylene flip-off cap.

NDC 17478-921-95          500 mL in a 570 mL container.

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

AKORN

Manufactured for: Akorn, Inc.
Lake Forest, IL 60045

Made in Austria

BSA0N Rev. 10/16

Principal Display Panel Text for Container Label

NDC 17478-921-95

Balanced Salt Solution

Sterile Irrigating Solution

NOT FOR INTRAVENOUS USE SINGLE-DOSE UNIT

Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%,
calcium chloride •2H2O 0.048%, magnesium chloride •6H2O 0.03%, sodium
acetate •3H2O 0.39%, sodium citrate • 2H2O 0.17%, sodium hydroxide and/or
hydrochloric acid (to adjust pH), and water for injection.

The pH is approximately 7.0.

The osmolality is approximately 300 mOsm/Kg.

STERILE 500 mL Rx Only

BALANCED SALT 
sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and trisodium citrate dihydrate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-921
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium chloride (chloride ion and sodium cation) sodium chloride 6.4 mg  in 1 mL
potassium chloride (potassium cation and chloride ion) potassium chloride 0.75 mg  in 1 mL
calcium chloride (calcium cation and chloride ion) calcium chloride 0.48 mg  in 1 mL
magnesium chloride (magnesium cation and chloride ion) magnesium chloride 0.3 mg  in 1 mL
sodium acetate (acetate ion and sodium cation) sodium acetate 3.9 mg  in 1 mL
trisodium citrate dihydrate (anhydrous citric acid) anhydrous citric acid 1.7 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium hydroxide  
hydrochloric acid  
water  
Packaging
# Item Code Package Description
1 NDC:17478-921-95 1 BOTTLE, GLASS in 1 BOTTLE
1 500 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075503 11/27/2014
Labeler - Akorn, Inc. (062649876)
Revised: 02/2015   Akorn, Inc.
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