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Sodium Chloride by Rite Aid Corporation

Dosage form: solution/ drops
Ingredients: Sodium Chloride 50mg in 1mL
Labeler: Rite Aid Corporation
NDC Code: 11822-5458

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.

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) every 3 or 4 hours, or as directed by a doctor.

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.

Questions

call 1-800-579-8327

Principal Display Panel Text for Container Label:

RITE
AID®
PHARMACY

eye care
ophthalmic
solution
sodium chloride USP 5%
hypertonicity
eye drops
Sterile
0.5 FL OZ (15 mL)

Principal Display Panel Text for Carton Label:

RITE                      Compare to the active
AID®                     ingredient in Muro-128®*
PHARMACY         NDC 11822-5458-1
eye care
ophthalmic
solution
sodium chloride USP 5%
hypertonicity
eye drops
temporary relief
of corneal edema
doctor recommended
Sterile
0.5 FL OZ (15 mL)

SODIUM CHLORIDE 
sodium chloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5458
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:11822-5458-11 BOTTLE, DROPPER in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/21/2013
Labeler - Rite Aid Corporation (014578892)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc063434679PACK(11822-5458), LABEL(11822-5458)
Establishment
NameAddressID/FEIOperations
Akorn, Inc. 155135783MANUFACTURE(11822-5458), ANALYSIS(11822-5458), STERILIZE(11822-5458)

 
Rite Aid Corporation

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Medically reviewed on Feb 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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