Label: SODIUM CHLORIDE- sodium chloride ointment

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Sodium Chloride 5%

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  • Purpose

    Hypertonicity agent

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  • Use

    for temporary relief of corneal edema.

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  • 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.

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  • 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.

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  • 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.
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  • Inactive ingredients

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

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-622-35 Akorn Logo

    Sodium Chloride Ophthalmic

    Ointment USP, 5%

    Hypertonicity Eye Ointment Sterile

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

    Principal Display Panel Text for Container Label
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  • 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 (1/8oz.)

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17478-622
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Chloride (Sodium Cation and Chloride Ion) Sodium Chloride 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Mineral Oil  
    Lanolin  
    Water  
    Petrolatum  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-622-35 1 in 1 CARTON
    1 3.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 05/08/2006
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(17478-622), ANALYSIS(17478-622), STERILIZE(17478-622), PACK(17478-622), LABEL(17478-622)
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