SODIUM CHLORIDE- sodium chloride solution/ drops 
Akorn, Inc.

Disclaimer: 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.

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Sodium Chloride Ophthalmic Solution, USP

Drug Facts

Active ingredient

Sodium Chloride 5%

Purpose

Hypertonicity Agent

Use

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

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 Container Label

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

Principal Display Panel Text for Carton Label
SODIUM CHLORIDE 
sodium chloride solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17478-623
Route of Administration OPHTHALMIC DEA Schedule     
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:17478-623-12 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 04/01/1998
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc. 063434679 LABEL(17478-623) , PACK(17478-623)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc. 155135783 MANUFACTURE(17478-623) , ANALYSIS(17478-623) , STERILIZE(17478-623)

Revised: 3/2012
Document Id: f4ab05eb-c2f7-4505-975c-8b2d554cfd3a
Set id: ab12c419-4b1a-4119-9e23-76ce7a89d1a7
Version: 1
Effective Time: 20120302
 
Akorn, Inc.