Label: SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC- sodium chloride ointment

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 20, 2024

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  • Active ingredient

    Sodium chloride 50 mg (5%)

  • Purpose

    Hypertonicity agent

  • Uses

    temporary relief of corneal edema

  • Warnings

    For external use only

    Do not useexcept under the advice and supervision of a doctor

    When using this product

    • it may cause temporary burning and irritation
    • replace cap after use
    • to avoid contamination do not touch tip of container to any surface

    Stop use and ask a doctor if

    • condition worsens or persists for more than 72 hours
    • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • Keep Out of Reach of Children

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

  • Directions

    • pull down the lower lid of the affected eye
    • apply a small amount (1/4 inch) of ointment to the inside of eyelid
    • apply every 3 or 4 hours or as directed by a doctor
  • Other information

    • store at 15° - 25°C (59° - 77°F)
    • keep tightly closed
    • DO NOT FREEZE
    • see crimp of tube or carton for Lot Number and Expiration Date
    • do not use if difficult to dispense or visible particles are seen in the product
    • serious side effects associated with use of the product may be reported to the phone number below
  • Inactive ingredients

    lanolin, mineral oil, purified water, white petrolatum

  • Questions[phone icon]

    Call 1-800-645-2158

  • Package/Label Principal Display Panel Carton

    Rugby®

    NDC 0536-1253-91

    Sodium Chloride Hypertonicity
    Ophthalmic Ointment, 5%

    1. STERILE NET WT. 1/8 OZ. (3.5 G)
    carton
  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 
    sodium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1253
    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
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1253-911 in 1 CARTON11/06/2020
    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 DrugM01811/06/2020
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625manufacture(0536-1253)