SODIUM CHLORIDE solution/ drops

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Otc medication manufactured, distributed, or labeled by Akorn, Inc., Akorn, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Chloride 5%

Purpose

Hypertonicity Agent

Use

• for temporary relief of corneal edema.

Warnings

Do not use

• this product except under the advice and supervision of a doctor.
• if imprinted seal is broken or missing.
• if solution changes color or becomes cloudy.

When using this product

• temporary burning and irritation upon being instilled into eye may occur.
• to avoid contamination, do not touch tip of container to any surface
• replace cap after each use

Stop use and ask a doctor if

• you experience eye pain.
• you experience changes in vision.
• redness or irritation of the eye continues
• condition worsens or persists.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• Store at 20° to 25°C (68° to77°F) [see USP Controlled Room Temperature].
• Keep tightly closed.

Inactive ingredients

Boric Acid, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylparaben 0.1 mg (0.01%), Propylene Glycol, Sodium Borate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (6.0 to 8.0), and Water for Injection.

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-623-12 Akorn Logo
5%
SODIUM
CHLORIDE
Ophthalmic
Solution, USP

Hypertonicity
Eye Drops
15 mL (0.5 fl. oz.) Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 17478-623-12
5%
SODIUM
CHLORIDE
Ophthalmic
Solution, USP

Hypertonicity Eye Drops

Comparable to Muro-128®*
15 mL (0.5 fl. oz.) Sterile

Akorn Logo

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17478-623
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Chloride	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid (UNII: R57ZHV85D4)
Hypromelloses (UNII: 3NXW29V3WO)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Borate (UNII: 91MBZ8H3QO)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)
Water (UNII: 059QF0KO0R)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-623-12	1 in 1 CARTON	04/01/1998
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/01/1998

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		063434679	LABEL(17478-623) , PACK(17478-623)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		155135783	MANUFACTURE(17478-623) , ANALYSIS(17478-623) , STERILIZE(17478-623)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		603980319	ANALYSIS(17478-623) , LABEL(17478-623) , MANUFACTURE(17478-623) , PACK(17478-623) , STERILIZE(17478-623)