Label: ARTIFICAL TEARS- glycerin 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 December 3, 2018

If you are a consumer or patient please visit this version.

  • 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

    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: 1-866-767-8975

    U.S. Patent No. 5,800,807

    DISTRIBUTED BY: RITE AID

    30 HUNTER LANE, CAMP HILL, PA 17011

    MADE IN USA

    © RITE AID

    ITEM 398549

    3123703

  • Package/Label Principal Display Panel

    Rite Aid 30mL Artificial Tears Carton

    RITE

    AID®

    PHARMACY

    eye care

    artificial

    tears

    lubricant eye drops

    DRY EYE FORMULA

    fast relief from

    age-related dry eyes

    replenishes tears

    refreshes eyes

    Sterile

    1 FL OZ (30 mL)

  • INGREDIENTS AND APPEARANCE
    ARTIFICAL TEARS 
    glycerin and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9854
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.3 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1 g  in 100 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:11822-9854-91 in 1 CARTON09/01/2010
    130 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 finalpart34909/01/2010
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Baush & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598MANUFACTURE(11822-9854)