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

QUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-968-15
Set ID a829b0de-65dd-4e60-8090-64d0a064df32
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

    Polyethylene Glycol 400 (0.4%)..................................Lubricant

    Propylene Glycol (0.3%).............................................Lubricant

  • PURPOSE

    Uses

    For the relief of burning, irritation due to dryness of the eye.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

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

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if

    • you experience 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 immediately.

  • INDICATIONS & USAGE

    Directions

    • Put 1 or 2 drops in the affected eye(s) as needed.
  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

    Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride

  • 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 EYE  
    polyethylene glycol 400, propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-968
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) 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
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-968-151 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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