Label: SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION- sodium chloride solution

  • Category: HUMAN OTC DRUG LABEL

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 September 17, 2020

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  • Drug Facts

  • Active ingredients

    Sodium chloride 5%

  • Purpose

    Hypertonicity agent

  • Uses

    temporary relief of corneal edema

  • Warnings

    Do not use

    •
    except under the advice and supervision of a doctor
    •
    if solution changes color or becomes cloudy

    When using this product  

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

    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

     
    instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.
  • Other information

    •
    store upright at 15° - 25°C (59° - 77°F)
    •
    keep tightly closed
    •
    serious side effects associated with use of the product may be reported to the phone number provided below

     

  • Inactive ingredients

    boric acid, hypromellose, propylene glycol, purified water, sodium borate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVES ADDED: methylparaben 0.023%, propylparaben 0.01%.

  • Questions?

    [phone icon] Call 1-800-645-2158

  • Package/Label Principal Display Panel – carton

    carton

    NDC 0536-1254-94

    Rugby®

    Sodium Chloride
    Hypertonicity
    Ophthalmic
    Solution, 5%

    STERILE

    1/2 FL. OZ. (15 mL)

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION 
    sodium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1254
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1254-941 in 1 CARTON09/17/2020
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/17/2020
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(0536-1254)
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