Label: ARTIFICIAL TEARS LUBRICANT EYE DROPS- glycerin, 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 November 22, 2021

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  • Active ingredients

    Glycerin (0.3%)

    Propylene glycol (1.0%)

  • Purpose

    Lubricant

    Lubricant

  • Uses

    •
    temporary relief of burning and irritation due to dryness of the eye
    •
    prevents further irritation
  • Warnings

    For external use only

    Do not use

    •
    if solution changes color or becomes cloudy

    When using this product

    •
    do not touch tip of container to any surface to avoid contamination
    •
    remove contact lenses before using
    •
    replace cap after use

    Stop use and ask a doctor if

    •
    you experience 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    instill 1 or 2 drops in the affected eye(s) as needed
  • Other information

    •
    store at 15°-25°C (59°-77°F)
    •
    keep tightly closed
    •
    use before expiration date marked on the carton and bottle
    •
    serious side effects associated with use of the product may be reported to the phone number provided below
  • Inactive ingredients

    benzalkonium chloride (0.01%), boric acid, edetate disodium, potassium chloride, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

  • Questions?

    Call: 1-866-767-9161

  • Package/Label Principal Display Panel

    CVS Artificial Tears 30 mL Carton

    CVS
    Health™

    Artificial

    Tears

    LUBRICANT EYE DROPS

    •
    Relieves dry, irritated eyes
    •
    Soothes & lubricates

    [icon] blue heart with drop inside

    STERILE

    1 FL OZ (30 mL)

  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS LUBRICANT EYE DROPS 
    glycerin, propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-454
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-454-301 in 1 CARTON09/01/2010
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/01/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Bausch & Lomb Incorporate (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598MANUFACTURE(69842-454)
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