Label: RUGBY LUBRICATING EYE DROPS- polyethylene glycol, propylene glycol liquid

  • 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 February 21, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Polyethylene glycol 400  0.4%
    Propylene glycol   0.3%

  • PURPOSE

    Purpose

    Polyethylene glycol 400............. Lubricant
    Propylene glycol............ Lubricant

  • INDICATIONS & USAGE

    Uses
    • for the temporary relief of burning and irritation due to dryness of the eye

  • WARNINGS

    Warnings
    For external use only

    Do not use
    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product

    When using this product
    • do not touch the tip of container to any surface to avoid contamination
    • replace cap after each 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 or lasts more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • DOSAGE & ADMINISTRATION

    Directions
    • Instill 1 or 2 drops in the affected eye(s) as needed
    • Children under 6 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • RETAIN THIS CARTON FOR FUTURE REFERENCE
    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride.

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    RUGBY LUBRICATING EYE DROPS 
    polyethylene glycol, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1219
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1219-941 in 1 BOX02/19/2019
    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 finalpart34902/19/2019
    Labeler - Rugby Laboratories (079246066)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(0536-1219) , pack(0536-1219) , label(0536-1219)
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