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 January 27, 2022

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  • 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) 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

    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 Container Label:
  • PRINCIPAL DISPLAY PANEL

    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)

    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:11822-5458
    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:11822-5458-11 in 1 CARTON02/21/2013
    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 finalpart34902/21/2013
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696790PACK(11822-5458) , LABEL(11822-5458)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696832MANUFACTURE(11822-5458) , ANALYSIS(11822-5458) , STERILIZE(11822-5458)
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