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 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
    • do not use if cap skirt is dislodged from tube
    • 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 occur
    • continued redness or irritation of the eye
    • 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 Lot Number and Expiration Date
    • Retain this carton for future reference
  • Inactive ingredients

    • Mineral Oil, Modified Lanolin, Water for Injection and White Petrolatum.
  • Questions or comments?

    1-800-932-5676

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    STERILE Well at

    Sodium Chloride Walgreens

    Ophthalmic Ointment NDC 0363-9050-00

    USP, 5% NET WT 3.5 g (1/8 oz.)

    Hypertonicity Eye Ointment

    FOR OPHTHALMIC USE ONLY

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    STERILE Well at

    Walgreens NDC 0363-9050-00

    WALGREENS PHARMACIST RECOMMENDED≠

    Sodium Chloride

    Ophthalmic Ointment

    USP, 5%

    Hypertonicity Eye Ointment

    Compare to Muro 128®

    Ointment active ingredient#

    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:0363-9050
    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:0363-9050-001 in 1 CARTON02/12/2013
    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 finalpart34902/12/2013
    Labeler - Walgreens (008965063)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE(0363-9050) , ANALYSIS(0363-9050) , STERILIZE(0363-9050) , PACK(0363-9050) , LABEL(0363-9050)
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