Label: SODIUM CHLORIDE solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated July 1, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    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 Water for Injection.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-623-12
    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

    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
  • INGREDIENTS AND APPEARANCE
    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 (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696790LABEL(17478-623) , PACK(17478-623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696832MANUFACTURE(17478-623) , ANALYSIS(17478-623) , STERILIZE(17478-623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840ANALYSIS(17478-623) , LABEL(17478-623) , MANUFACTURE(17478-623) , PACK(17478-623) , STERILIZE(17478-623)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!