GOODSENSE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL) SOLUTION/ DROPS [GEISS, DESTIN & DUNN, INC]

GOODSENSE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL) SOLUTION/ DROPS [GEISS, DESTIN & DUNN, INC]
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NDC 50804-665-30
Set ID 6936237e-a8f1-8414-e053-2a91aa0a1c87
Category HUMAN OTC DRUG LABEL
Packager Geiss, Destin & Dunn, Inc
Generic Name
Product Class
Product Number
Application Number PART349
  • 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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