Label: SODIUM CHLORIDE solution/ drops

  • Category: HUMAN OTC DRUG LABEL

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 May 5, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Walgreens Sodium Chloride Ophthalmic

     Solution, 5% Hypertonicity Eye Drops 15mL  

    NDC 0363-0193-13

    Drug Facts

  • Active ingredient

    Sodium Chloride 5%

  • Purpose

    Hypertonicity Agent

  • Use

    • For the temporary relief of corneal edema.

  • Warnings

    For use in the eyes only

    Save box for complete information

    Do not use 

    • except under the advice and supervision of a doctor.

    • if solution changes color or becomes cloudy.

    When using this product

    • keep tightly closed.

    • to avoid contamination, do not touch tip of container to any surface.

    • replace cap immediately after each use.

    • this product may cause temporary burning and irritation on being instilled into the eye.

    Stop use and ask a doctor if  

    • you experience eye pain. • changes in your vision occur.

    • continued redness or irritation of the eye persists.

    • condition worsens or persists.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • instill 1 or 2 drops in the affected eye(s) every 3 to 4 hours, or as directed by a doctor.

  • Other information

    • replace cap after using and keep tightly closed.

    • store at 15° to 30°C (59° to 86°F).

    • remove contact lenses before using.

  • Inactive ingredients

    Boric Acid, Hypromellose, Methylparaben, Propylene Glycol, Propylparaben, Sodium Borate, and Water for injection. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH.

  • Questions?

    • 1-800-925-4733  • 9am – 5pm EST Monday - Friday

  • PRINCIPAL DISPLAY PANEL

    Walgreens

    NDC 0363-0193-13

    Sodium Chloride

    Ophthalmic

    Solution, 5%

    Hypertonicity

    Eye Drops

    0.5 FL OZ (15 mL)

    CartonLabel

    CartonLabel

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0193
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0193-131 in 1 BOX04/01/2019
    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 finalpart34904/01/2019
    Labeler - Walgreen Company (008965063)