SODIUM CHLORIDE solution/ drops

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Otc medication manufactured, distributed, or labeled by Walgreens, Akorn, Inc., 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 on bottle is missing or broken
• 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° to 77°F) [see USP Controlled Room Temperature].
• keep tightly closed.

Inactive ingredients

Boric Acid, Hydrochloric Acid*, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylene Glycol, Propylparaben 0.1 mg (0.01%), Water for Injection, Sodium Borate, Sodium Hydroxide*. *May contain one or more of these ingredients to adjust pH (6.0 to 8.0).

Questions or Comments?

1-800-932-5676

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Well at

Walgreens NDC: 0363-9040-00

STERILE

Sodium Chloride

Ophthalmic

Solution USP, 5%

Hypertonicity Eye Drops

0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Well at

Walgreens NDC: 0363-9040-00

WALGREENS PHARMACIST RECOMMENDED≠

STERILE

Sodium Chloride

Ophthalmic

Solution USP, 5%

Hypertonicity Eye Drops

0.5 FL OZ (15 mL)

Compare to Muro 128®

active ingredient#

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9040
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: 0363-9040-00	1 in 1 CARTON	02/12/2013
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	02/12/2013

Labeler - Walgreens (008965063)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		063434679	PACK(0363-9040) , LABEL(0363-9040)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		155135783	MANUFACTURE(0363-9040) , ANALYSIS(0363-9040) , STERILIZE(0363-9040)