Label: REFRESH TEARS- carboxymethylcellulose sodium 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 8, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Carboxymethylcellulose sodium 0.5%

  • Purpose

    Eye lubricant

  • Uses

    • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
    • May be used as a protectant against further irritation.
  • Warnings

    • For external use only.
    • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
    • If solution changes color or becomes cloudy, do not use.

    Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the 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

    • Use only if imprinted tape seal on bottle is intact and clearly legible.
    • Use before expiration date marked on container.
    • Store at 59°-86°F (15°-30°C).
    • RETAIN THIS CARD FOR FUTURE REFERENCE.
  • Inactive ingredients

    Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or comments?

    1.800.433.8871 M–F 6 AM – 4:30 PM Pacific Time
    refreshbrand.com

  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed by Convenience Valet®
    Melrose Park, IL 60160

  • PRINCIPAL DISPLAY PANEL - 3 mL Bottle Label

    CONVENIENCE
    CV
    VALET    ®

    PERSONAL
    CARE

    Refresh
    Tears    ®
    Lubricant Eye Drops

    0.1 fl oz (3 mL) Sterile

    PRINCIPAL DISPLAY PANEL - 3 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    REFRESH TEARS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1073(NDC:0023-0798)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    boric acid (UNII: R57ZHV85D4)  
    calcium chloride (UNII: M4I0D6VV5M)  
    magnesium chloride (UNII: 02F3473H9O)  
    potassium chloride (UNII: 660YQ98I10)  
    water (UNII: 059QF0KO0R)  
    sodium chlorite (UNII: G538EBV4VF)  
    sodium chlorate (UNII: T95DR77GMR)  
    chlorine dioxide (UNII: 8061YMS4RM)  
    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:29485-1073-01 in 1 PACKAGE
    13 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34901/01/2010
    Labeler - Mechanical Servants, Inc. (005530951)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allergan, Inc.362898611MANUFACTURE(29485-1073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mechanical Servants, Inc.005530951RELABEL(29485-1073)
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