RxNorm Names

Review RxNorm Normal Forms

SODIUM CHLORIDE solution/ drops
[Walgreens]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69d1b3e9-60b9-4b0f-ac43-eb420395106f

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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 Purified Water USP.

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 Text for Container Label

Principal Display Panel Text for Carton Label:

Well at

Walgreens NDC 0363-9040-00

WALGREENS PHARMACIST RECOMMENDED≠

NEW

STERILE

Sodium Chloride

Ophthalmic

Solution USP, 5%

Hypertonicity Eye Drops

0.5 FL OZ (15 mL)

Compare to Muro 128®

active ingredient#

Principal Display Panel Text for Carton Label

SODIUM CHLORIDE
sodium chloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-9040
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (Sodium Cation)	Sodium Chloride	50 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid
Hypromelloses
Propylene Glycol
Sodium Borate
Sodium Hydroxide
Hydrochloric Acid
Water
Methylparaben
Propylparaben

Packaging
#	Item Code	Package Description
1	NDC:0363-9040-00	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER

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)

Revised: 02/2013

Document Id: bb751db2-142b-4507-803a-cb65e349e4c2

Set id: 69d1b3e9-60b9-4b0f-ac43-eb420395106f

Version: 1

Effective Time: 20130212

Walgreens

Daily Med

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