Sodium Chloride Ophthalmic Solution, USP

Sodium Chloride Ophthalmic Solution, USP

Drug Labeling and Warnings

Drug Details

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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

  • 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 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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 17478-623
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 17478-623-121 in 1 CARTON04/01/1998
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/01/1998
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.063434679LABEL(17478-623) , PACK(17478-623)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc. 155135783MANUFACTURE(17478-623) , ANALYSIS(17478-623) , STERILIZE(17478-623)

Revised: 3/2012
 
Akorn, Inc.


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