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Sodium Chloride by Akorn, Inc.

Dosage form: solution/ drops
Ingredients: Sodium Chloride 50mg in 1mL
Labeler: Akorn, Inc.
NDC Code: 17478-623

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.

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 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-623
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (Sodium Cation) Sodium Chloride50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Boric Acid 
Hypromelloses 
Propylene Glycol 
Sodium Borate 
Sodium Hydroxide 
Hydrochloric Acid 
Water 
Methylparaben 
Propylparaben 
Packaging
#Item CodePackage Description
1NDC:17478-623-121 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/01/1998
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc.063434679LABEL(17478-623), PACK(17478-623)
Establishment
NameAddressID/FEIOperations
Akorn, Inc. 155135783MANUFACTURE(17478-623), ANALYSIS(17478-623), STERILIZE(17478-623)

Revised: 03/2012
 
Akorn, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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