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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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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 DrugM01802/12/2021
    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)