SODIUM CHLORIDE solution/ drops

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, 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) every 3 or 4 hours, or as directed by a doctor.

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 Purified Water USP.

Questions

call 1-800-579-8327

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

RITE
AID®
PHARMACY

eye care
ophthalmic
solution
sodium chloride USP 5%
hypertonicity
eye drops
Sterile
0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

RITE                      Compare to the active
AID®                     ingredient in Muro-128®*
PHARMACY         NDC: 11822-5458-1
eye care
ophthalmic
solution
sodium chloride USP 5%
hypertonicity
eye drops
temporary relief
of corneal edema
doctor recommended
Sterile
0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-5458
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: 11822-5458-1	1 in 1 CARTON	02/21/2013
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	02/21/2013

Labeler - Rite Aid Corporation (014578892)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		063434679	PACK(11822-5458) , LABEL(11822-5458)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		155135783	MANUFACTURE(11822-5458) , ANALYSIS(11822-5458) , STERILIZE(11822-5458)