QUALITY CHOICE LUBRICANT TEARS EYE (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]

QUALITY CHOICE LUBRICANT TEARS EYE (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-967-15
Set ID ac9fb8ee-d0b9-43dc-900b-1362b56974cc
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION INC
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredients                                                                             Purpose

    Glycerin 0.2%..................................................................................Lubricant

    Hypromellose 0.2%..........................................................................Lubricant

    Polyethylene glycol 400 1%..............................................................Lubricant

  • PURPOSE

    Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for protection against further irritation
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use:

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

    When using this product

    • remove contact lenses before use
    • do not use if this solution changes color or becomes cloudy
    • 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 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 right away

  • INDICATIONS & USAGE

    Directions

    • 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

    • some users may experience a brief tingling sensation
    • store at 15o to 25oC (59o to 77oF)
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, dextrose, glycine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate.

  • DOSAGE & ADMINISTRATION

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE LUBRICANT TEARS EYE  
    glycerin, hypromellose, polyethylene glycol 400 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-967
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES2 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-967-151 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/30/2012
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

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