RUGBY ULTRA LUBRICANT EYE (POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL) SOLUTION/ DROPS [RUGBY LABORATORIES]

RUGBY ULTRA LUBRICANT EYE (POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL) SOLUTION/ DROPS [RUGBY LABORATORIES]
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NDC 0536-1104-94
Set ID 6aa339d2-9e19-4cc4-ae44-49693fcc8345
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredients                                   Purpose

    Polyethylene glycol 400 0.4%..................Lubricant

    Propylene glycol 0.3%............................Lubricant

  • PURPOSE

    Uses

    For the temporary relief of burning and irritation due to dryness of the eye

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
  • WHEN USING

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of childern.

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

  • INDICATIONS & USAGE

    Directions

    • Shake well before using.
    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature.
  • INACTIVE INGREDIENT

    Inactive ingredients

    boric acid, calcium chloride, chlorhexidine gluconate (20%), hydrochloric acid, hypromellose 2910, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI 48150

    www.rugbylaboratories.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RUGBY ULTRA LUBRICANT EYE 
    polyethylene glycol 400, and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1104
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1104-941 in 1 BOX04/27/2016
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/27/2016
    Labeler - Rugby Laboratories (079246066)