Label: GNP LUBRICANT EYE- polyethylene glycol 400 solution/ drops

  • 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 June 30, 2013

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  • 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) get 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 right away.

  • INDICATIONS & USAGE

    Directions

    • Instill 1 to 2 drops in the affected eye(s) as needed
    • Children under 6 years of age: Ask a doctor.
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature.
    • Do not use if carton is open or neckband on the bottle is broken or missing.
  • INACTIVE INGREDIENT

    Inactive ingredients: Boric Avid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hypromellose 2910, Magnesium Chloride, Potassium Chloride, Purified Water, Sodim Chloride, Sodium Hydroxide, Zinc Chloride

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Amerisource Bergen Corporation

    1300 Morris Drive

    Chesterbrook, PA 19087  

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    GNP LUBRICANT EYE  
    polyethylene glycol 400 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-018
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOLS - UNII:3WJQ0SDW1A) POLYETHYLENE GLYCOL 4000.4 mg  in 1 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    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:46122-018-051 in 1 CARTON
    115 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/30/2013
    Labeler - Amerisource Bergen (007914906)
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