Label: CVS HYDRATION EYE DROPS- polyetylene glycol 400, 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 January 19, 2023

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  • Active ingredients

    Polyethylene glycol 400 0.4%

    Propylene glycol 0.3%

  • Purposes

    Lubricant

    Lubricant

  • Use

    • 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 the tip of container to any surface to avoid contamination
    • replace cap after each use

    Stop use and ask a doctor

    if you experience any of the following:

    • eye pain
    • changes in vision occur
    • continued redness or irritation of the eye
    • condition worsens or persists for more than 72 hours

    Keep out of reach of childeren.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    put 1 or 2 drops in the affected eye(s) as needed

  • Other information

    Store at temperature, not exceeding 59°F (15°C)

  • Inactive ingredients

    boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium hydroxide

  • CVS Hydration Eye Drops

    CVS Hydration Eye Drops

  • INGREDIENTS AND APPEARANCE
    CVS HYDRATION EYE DROPS 
    polyetylene glycol 400, propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-615
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    BORIC ACID (UNII: R57ZHV85D4)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-615-101 in 1 BOX01/19/2023
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/19/2023
    Labeler - CVS (062312574)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed688016567manufacture(51316-615) , pack(51316-615) , label(51316-615)
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