BALANCED SALT- calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate solution

BALANCED SALT by

Drug Labeling and Warnings

BALANCED SALT by is a Prescription medication manufactured, distributed, or labeled by Akorn, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

BALANCED SALT SOLUTION is a sterile physiological solution containing calcium chloride (CaCl2·2H2O), magnesium chloride (MgCl2·6H2O), potassium chloride (KCl), sodium acetate (C2H3NaO2·3H2O), sodium chloride (NaCl) and sodium citrate (C6H5Na3O7·2H2O). This solution is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions. Each 1 mL contains:

Calcium Chloride	(MW 147.02)	0.48 mg
Magnesium Chloride	(MW 203.31)	0.30 mg
Potassium Chloride	(MW 74.56)	0.75 mg
Sodium Acetate	(MW 136.08)	3.90 mg
Sodium Chloride	(MW 58.44)	6.40 mg
Sodium Citrate	(MW 294.10)	1.70 mg
Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
Water for Injection; 7.0 pH and 300 mosm/kg osmolality.

CLINICAL PHARMACOLOGY

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

INDICATIONS AND USAGE

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

WARNINGS

• NOT FOR INJECTION OR INTRAVENOUS INFUSION.
• Do not use unless product is clear, seal is intact, 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.

PRECAUTIONS

Open under aseptic conditions only.

Prior to use, check the following: tip should be firmly in place, irrigating needle should be properly seated; squeeze out several drops before inserting into anterior chamber. The needle should be removed from the anterior chamber prior to releasing pressure to prevent suction.

Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution (Sterile Irrigating Solution) was used as an irrigating solution.

ADVERSE REACTIONS

Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

DOSAGE AND ADMINISTRATION

18 mL bottle: The adaptor plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the bottle as explained below. External irrigation may be done without the irrigating needle.

Method for Using Adaptor Plug for Ophthalmic Irrigating Needle:

1. Aseptically remove bottle from pouch by peeling backing.
2. Snap on surgeon's sterile irrigation needle. Push until firmly in place.
3. Test assembly for proper function before use.

HOW SUPPLIED:

NDC: 17478-920-19 18 mL bottle

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze.

AKORN
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
BLA0N Rev. 10/16

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-920-19 Akorn Logo

BALANCED

SALT SOLUTION

Rx only

NOT FOR INJECTION

OR INTRAVENOUS USE.

18 mL Sterile Single Dose Bottle

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 17478-920-19 Akorn Logo

BALANCED SALT SOLUTION

30 Sterile Single Dose Bottles (18 mL each)

NOT FOR INJECTION OR INTRAVENOUS USE.

INGREDIENTS AND APPEARANCE

BALANCED SALT 
calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 17478-920
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Calcium Chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB)	Calcium Chloride	0.48 mg  in 1 mL
Magnesium Chloride (UNII: 02F3473H9O) (magnesium cation - UNII:T6V3LHY838)	Magnesium Chloride	0.3 mg  in 1 mL
Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	Potassium Chloride	0.75 mg  in 1 mL
Sodium Acetate (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Acetate	3.90 mg  in 1 mL
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	6.40 mg  in 1 mL
Sodium Citrate (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Citrate	1.70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-920-19	1 in 1 POUCH	09/27/2006
1		18 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075503	09/27/2006

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		155135783	MANUFACTURE(17478-920) , REPACK(17478-920) , ANALYSIS(17478-920) , LABEL(17478-920) , PACK(17478-920) , RELABEL(17478-920) , STERILIZE(17478-920)