QC ULTRA LUBRICANT EYE (POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]

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QC ULTRA LUBRICANT EYE (POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-634-04
Set ID 76d3bcce-d654-4808-8f86-d6467bbdc997
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association Inc
Generic Name
Product Class
Product Number
Application Number PART349
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  • ACTIVE INGREDIENT

    Active ingredients                                           Purpose
    Polyethylene glycol 400 0.4%.............................Lubricant
    Propylene glycol 0.3%.........................................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 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
    • do not reuse
    • once opened, discard
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists 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 or 2 drops in the affected eye(s) as needed.
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    aminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium hydroxide, sorbitol, water for injection

  • 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 description

  • INGREDIENTS AND APPEARANCE
    QC ULTRA LUBRICANT EYE 
    polyethylene glycol 400, and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-634
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-634-0425 in 1 CARTON09/30/2016
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/30/2016
    Labeler - Chain Drug Marketing Association Inc (011920774)
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