Label: CVS SINGLE USE LUBRICANT EYE DROPS- 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 1, 2018

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  • ACTIVE INGREDIENT

    Active ingredients PurposePolyethylene glycol 400 0.4%......................................LubricantPropylene glycrol 0.3%...............................................Lubricant

  • PURPOSE

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

  • WARNINGS

    Warnings For external use only.

  • DO NOT USE

  • WHEN USING

    When using this productdo not touch tip of container to any surface to avoid contaminationdo not reuseonce opened, discard

  • STOP USE

    Stop use and ask a doctor ifyou feel eye painchanges in vision occurredness or irritation of the eye(s) get worse, persists or lasts 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.

  • DOSAGE & ADMINISTRATION

    Ophthalmic - Administration to the external eye.

  • INDICATIONS & USAGE

    Directions Instill 1 or 2 drops in the affected eye(s) as needed.

  • STORAGE AND HANDLING

    Other information Store at room temperature. Protect from light.

  • INACTIVE INGREDIENT

    Inactive ingredientsaminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium chloride, sodium hydroxide, sorbitol, water for injection

  • PRINCIPAL DISPLAY PANEL

    CVS eye drops

  • INGREDIENTS AND APPEARANCE
    CVS SINGLE USE LUBRICANT EYE DROPS 
    polyethylene glycol 400, and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-6553
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10564-6553-01 in 1 CARTON; Type 0: Not a Combination Product01/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/21/2016
    Labeler - Bershtel Enterprises LLC (066659129)
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