SODIUM CHLORIDE ointment

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.
• Do not use if bottom ridge of tube cap is exposed
• To avoid contamination, do not touch tip of container to any surface.
• Replace cap after using.
• May cause temporary burning and irritation upon application into the eye.

Stop use and ask a doctor if

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 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].
• Store away from heat.
• Protect from freezing.
• Keep tightly closed.
• See crimp for Control Number and Expiration Date.
• RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Mineral Oil, Modified Lanolin, Purified Water and White Petrolatum.

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-622-35 Akorn Logo

Sodium Chloride Ophthalmic

Ointment USP, 5%

Hypertonicity Eye Ointment Sterile

FOR OPHTHALMIC USE ONLY. Net Wt. 3.5 g (1/8oz.)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 17478-622-35

3.5 g

Sodium

Chloride

Ophthalmic

Ointment

USP, 5%

Hypertonicity

Eye Ointment

Comparable to MURO 128®

Sterile

Net Wt. 3.5 g (1/8oz.)

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17478-622
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698)	Sodium Chloride	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Mineral Oil (UNII: T5L8T28FGP)
Lanolin (UNII: 7EV65EAW6H)
Water (UNII: 059QF0KO0R)
Petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-622-35	1 in 1 CARTON	05/08/2006
1		3.5 g in 1 TUBE; 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	05/08/2006

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(17478-622) , ANALYSIS(17478-622) , STERILIZE(17478-622) , PACK(17478-622) , LABEL(17478-622)