Label: REFRESH TEARS- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 0023-0798-01, 0023-0798-02, 0023-0798-03, 0023-0798-04, view more
    0023-0798-15
  • Packager: Allergan, Inc.
  • 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 2, 2018

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

  • 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 seals on top and bottom flaps are intact and clearly legible.
    • Use before expiration date marked on container.
    • Discard 90 days after opening
    • Store at 59°-86°F (15°-30°C).
    • RETAIN THIS CARTON 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

    refreshbrand.com

  • PRINCIPAL DISPLAY PANEL

    Refresh
    Tears®
    Lubricating Eye Drops
    MOISTURIZING RELIEF
    Immediate, soothing
    relief for dry eyes
    0.5 fl oz (15 mL) Sterile

    PRINCIPAL DISPLAY PANEL
Refresh
Tears®
Lubricating Eye Drops
MOISTURIZING RELIEF
Immediate, soothing
relief for dry eyes 
0.5 fl oz (15 mL) Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH TEARS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0023-0798-041 in 1 CARTON05/16/1997
    13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-0798-031 in 1 CARTON05/16/1997
    23 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0023-0798-151 in 1 CARTON05/16/1997
    315 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4NDC:0023-0798-012 in 1 CARTON05/16/1997
    415 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    5NDC:0023-0798-024 in 1 CARTON05/16/1997
    515 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 FINALpart34905/16/1997
    Labeler - Allergan, Inc. (144796497)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allergan Sales, LLC362898611MANUFACTURE(0023-0798)