SODIUM CHLORIDE ointment

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Otc medication manufactured, distributed, or labeled by Walgreens, Akorn Operating Company LLC, 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 cap skirt is dislodged from tube
• 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 occur
• continued redness or irritation of the eye
• 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 Lot Number and Expiration Date
• Retain this carton for future reference

Inactive ingredients

• Mineral Oil, Modified Lanolin, Water for Injection and White Petrolatum.

Questions or comments?

1-800-932-5676

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

STERILE Well at

Sodium Chloride Walgreens

Ophthalmic Ointment NDC: 0363-9050-00

USP, 5% NET WT 3.5 g (1/8 oz.)

Hypertonicity Eye Ointment

FOR OPHTHALMIC USE ONLY

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

STERILE Well at

Walgreens NDC: 0363-9050-00

WALGREENS PHARMACIST RECOMMENDED≠

Sodium Chloride

Ophthalmic Ointment

USP, 5%

Hypertonicity Eye Ointment

Compare to Muro 128®

Ointment active ingredient#

NET WT 3.5 g (1/8 OZ)

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9050
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 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: 0363-9050-00	1 in 1 CARTON	02/12/2013
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	02/12/2013

Labeler - Walgreens (008965063)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(0363-9050) , ANALYSIS(0363-9050) , STERILIZE(0363-9050) , PACK(0363-9050) , LABEL(0363-9050)