Label: GOODSENSE LUBRICANT EYE- polyethylene glycol 400, and propylene glycol 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 April 20, 2018

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  • ACTIVE INGREDIENT

    Active ingredients Purposes

    Polyethylene glycol 400 0.4%........................................Eye lubricant

    Propylene glycol 0.3%...................................................Eye lubricant

  • PURPOSE

    Use

    • 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 the solution 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
    • do not reuse
    • once opened, discard
    • remove contact lenses before using
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) lasts
    • condition worsens or lasts more than 72 hours
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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.

  • INDICATIONS & USAGE

    Directions

    • to open, twist and pull tab to remove
    • instill 1 or 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 20-25°C (68-77°F)
    • protect from light
  • INACTIVE INGREDIENT

    Inactive ingredients

    aminomethylpropanol, boric acid, hydrochlorid acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride, sodium hydroxide, sorbitol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Geiss, Destin & Dunn, Inc.

    Peachtree City, GA 30269

    www.valuelabels.com

    Made in South Korea

  • PRINCIPAL DISPLAY PANEL

    89665

  • INGREDIENTS AND APPEARANCE
    GOODSENSE LUBRICANT EYE 
    polyethylene glycol 400, and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-665
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOLS - UNII:3WJQ0SDW1A) 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
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BORIC ACID (UNII: R57ZHV85D4)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-665-3030 in 1 CARTON04/18/2018
    10.4 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/17/2018
    Labeler - Geiss, Destin & Dunn, Inc (076059836)
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