Label: SODIUM CHLORIDE- sodium chloride solution/ drops

  • 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 02/13

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
    • if imprinted seal on bottle is missing or broken
    • 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.

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  • Directions

    Instill 1 or 2 drops in the affected eye(s) every 3 or 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].
    • keep tightly closed.
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  • Inactive ingredients

    Boric Acid, Hydrochloric Acid*, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylene Glycol, Propylparaben 0.1 mg (0.01%), Purified Water USP, Sodium Borate, Sodium Hydroxide*. *May contain one or more of these ingredients to adjust pH (6.0 to 8.0).

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  • Questions or Comments?

    1-800-932-5676

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    Well at

    Walgreens NDC 0363-9040-00

    STERILE

    Sodium Chloride

    Ophthalmic

    Solution USP, 5%

    Hypertonicity Eye Drops

    0.5 FL OZ (15 mL)

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Well at

    Walgreens NDC 0363-9040-00

    WALGREENS PHARMACIST RECOMMENDED≠

    STERILE

    Sodium Chloride

    Ophthalmic

    Solution USP, 5%

    Hypertonicity Eye Drops

    0.5 FL OZ (15 mL)

    Compare to Muro 128®

    active ingredient#

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-9040
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Chloride (Sodium Cation) Sodium Chloride 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Boric Acid  
    Hypromelloses  
    Propylene Glycol  
    Sodium Borate  
    Sodium Hydroxide  
    Hydrochloric Acid  
    Water  
    Methylparaben  
    Propylparaben  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-9040-00 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, DROPPER; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 02/12/2013
    Labeler - Walgreens (008965063)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 063434679 PACK(0363-9040), LABEL(0363-9040)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc. 155135783 MANUFACTURE(0363-9040), ANALYSIS(0363-9040), STERILIZE(0363-9040)
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