Label: SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC- 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 November 22, 2021

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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 use except 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%

     
    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 finalpart34911/06/2020
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(0536-1253)
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