Label: CVS LUBRICANT EYE DROPS ULTRA- polyethylene glycol 400, propylene glycol solution

  • 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 December 15, 2022

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  • ACTIVE INGREDIENT

    Active ingredients

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

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

  • PURPOSE

    Purposes

    Polyethylene glycol 400......Lubricant

    Propylene glycol.................Lubricant

  • INDICATIONS & USAGE

    Use

    • for the temporary relief of burning and irritation of the eye due to dryness of the eye
  • WARNINGS

    Warnings

    For external use only

    Do not use

    • if this solution 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 and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Instill 1 or 2 drops in the affected eye(s) as needed
  • OTHER SAFETY INFORMATION

    Other information

    • store at 15º-25º C (59º-77º F)
    • use only if single-use container is intact
    • use before expiration date marked on container
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • INACTIVE INGREDIENT

    Inactive ingredients

    boric acid, hydrochloric acid**, hypromellose, potassium chloride, purified water, sodium chloride, sodium hydroxide**

    ** May contain these ingredients to adjust pH.

  • PRINCIPAL DISPLAY PANEL

    60 ct carton30 ct carton

  • INGREDIENTS AND APPEARANCE
    CVS LUBRICANT EYE DROPS ULTRA 
    polyethylene glycol 400, propylene glycol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-752
    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
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-752-0130 in 1 CARTON02/12/2021
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:69842-752-0260 in 1 CARTON02/12/2021
    20.4 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 finalpart34902/12/2021
    Labeler - CVS (062312574)
    Registrant - K.C. Pharmaceutical, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460pack(69842-752) , label(69842-752)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed Pharmaceuticals, Inc.689852052manufacture(69842-752) , pack(69842-752) , label(69842-752)
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