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Sodium Chloride

Akorn, Inc.

Sodium Chloride Ophthalmic Solution, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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:

NDC 17478-623-12 Akorn Logo
5%
SODIUM
CHLORIDE
Ophthalmic
Solution, USP

Hypertonicity
Eye Drops
15 mL (0.5 fl. oz.) Sterile

Principal Display Panel Text for Carton Label:

NDC 17478-623-12
5%
SODIUM
CHLORIDE
Ophthalmic
Solution, USP

Hypertonicity Eye Drops

Comparable to Muro-128®*
15 mL (0.5 fl. oz.) Sterile

Akorn Logo

Sodium Chloride

Sodium Chloride SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:17478-623
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE 50 mg

Inactive Ingredients

Ingredient Name Strength
BORIC ACID
HYPROMELLOSES
propylene glycol
SODIUM BORATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water
METHYLPARABEN
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DROPPER
2 NDC:17478-623-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 1998-04-01


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Be sure to consult your doctor before taking any medication!
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