Label: SODIUM CHLORIDE ointment

  • 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 25, 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.
    • Do not use if bottom ridge of tube cap is exposed.
    • To avoid contamination, do not touch tip of container to any surface.
    • Replace cap after using.
    • May cause temporary burning and irritation upon application into the eye.

    Stop use and ask a doctor if

    you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

  • Keep out of the reach of children.

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

  • Questions or comments? 1-800-932-5676

  • Directions

    Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.

  • Other information

    • Store at controlled room temperature 20° to 25°C (68° to 77°F).
    • Store away from heat.
    • Protect from freezing.
    • Keep tightly closed.
    • See crimp for Control Number and Expiration Date.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Mineral Oil, Modified Lanolin, Purified Water and White Petrolatum.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    CVS Health™ Logo NDC 59779-303-01

    Sodium Chloride USP, 5%

    HYPERTONICITY OPHTHALMIC OINTMENT

    NET WT 0.125 OZ (3.5 g) STERILE

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    CVS Health™ Logo Compare to the active

    ingredient in Muro® 128*

    Sodium Chloride, NDC 59779-303-01

    USP, 5%

    HYPERTONICITY OPHTHALMIC OINTMENT

    Temporary relief of corneal edema

    NET WT 0.125 OZ (3.5 g) STERILE

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-303
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Mineral Oil (UNII: T5L8T28FGP)  
    Lanolin (UNII: 7EV65EAW6H)  
    Water (UNII: 059QF0KO0R)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-303-011 in 1 CARTON02/21/2013
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/21/2013
    Labeler - CVS Pharmacy (062312574)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE(59779-303) , ANALYSIS(59779-303) , STERILIZE(59779-303) , PACK(59779-303) , LABEL(59779-303)
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