Label: DRY EYE RELIEF- polyethylene glycol and propylene glycol gel

  • 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 June 30, 2021

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Polyethylene Glycol 400 0.4%           Lubricant
    Propylene Glycol 0.3% Lubricant
  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for use as a protectant against further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

  • Do not use

    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
  • 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 experience any of the following:

    • you feel eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • condition worsens or persists for 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.

  • Directions

    • shake well before using
    • put 1 or 2 drops in the affected eye(s) as needed
  • Other information

    • store at room temperature
  • Inactive ingredients

     boric acid, edetate disodium , potassium chloride, mangnesium chloride , sodium chloride, sodium borate , purified water.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    DRY EYE RELIEF 
    polyethylene glycol and propylene glycol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0088
    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
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM CHLORATE (UNII: M536P01U3N)  
    POTASSIUM CHLORATE (UNII: H35KS68EE7)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0088-110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/09/2021
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
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