Label: EXTREME RELIEF LUBRICANT- 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 March 4, 2015

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  • ACTIVE INGREDIENT

    Active ingredients                                                      Purpose

    Polyethylene glycol 400 0.4%................................... Lubricant

    Propylene glycol 0.3%............................................. Lubricant

  • PURPOSE

    Uses

    For the temporary relief of burning and irritation due to eye dryness

  • WARNINGS

    Warnings

    For external use only

    retain carton for full drug facts

  • DO NOT USE

    Do not use

    • if 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
    • 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(s) gets worse, persists or last more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Directions

    • Shake well before use
    • 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

    boric acid, calcium chloride, 20% chlorhexidine, glyconate, hydrochloric acid, hypromellose 2910, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    TARGET CORP.

    MINNEAPOLIS, MN 55403

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EXTREME RELIEF LUBRICANT 
    polyethylene glycol 400, and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-576
    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 CHLORATE (UNII: M536P01U3N)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-576-151 in 1 BOX
    115 mL in 1 BOTTLE, DROPPER
    2NDC:11673-576-302 in 1 BOX
    215 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/04/2015
    Labeler - Target Corporation (006961700)
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