Label: SODIUM CHLORIDE ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 7, 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 reach of children.

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

  • 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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
    • 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, Water for Injection and White Petrolatum.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-622-35

    Sodium Chloride Ophthalmic

    Ointment USP, 5%

    Hypertonicity Eye Ointment Sterile

    FOR OPHTHALMIC USE ONLY. Net Wt. 3.5 g (1/8 oz.)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-622-35

    3.5 g

    Sodium

    Chloride

    Ophthalmic

    Ointment

    USP, 5%

    Hypertonicity

    Eye Ointment

    Comparable to MURO 128®

    Sterile

    Net Wt. 3.5 g (1/8 oz.)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-622
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698) 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:17478-622-351 in 1 CARTON05/08/2006
    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 finalpart34905/08/2006
    Labeler - Akorn (117696770)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE(17478-622) , ANALYSIS(17478-622) , STERILIZE(17478-622) , PACK(17478-622) , LABEL(17478-622)
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