Label: REFRESH PLUS- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 0023-0403-05, 0023-0403-10, 0023-0403-30, 0023-0403-50, view more
    0023-0403-70
  • 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 February 9, 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. Do not reuse. Once opened, discard.
    • Do not touch unit-dose tip to eye.
    • 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

    To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

    *If used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions.

  • Other information   

    • Use only if single-use container is intact.
    • Use before expiration date marked on container.
    • Store at 59°-86°F (15°-30°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Calcium chloride; magnesium chloride; potassium chloride; purified water; sodium chloride; and sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or comments?

    1.800.433.8871

    refreshbrand.com

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-0403-30
    Preservative-free
    Refresh
    Plus
    Lubricant Eye Drops
    MOISTURIZING RELIEF 
    Immediate, soothing relief
    for dry eyes. Also recommended
    for LASIK dryness*
    30 Single-Use Containers
    0.01 fl oz (0.4 mL) each Sterile

    PRINCIPAL DISPLAY PANEL
NDC 0023-0403-30
Preservative-free
Refresh
Plus
Lubricant Eye Drops
MOISTURIZING RELIEF 
Immediate, soothing relief 
for dry eyes. Also recommended 
for LASIK dryness*
30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-0403-30
    Preservative-free
    Refresh
    Plus
    Lubricant Eye Drops
    MOISTURIZING RELIEF
    Immediate, soothing relief
    for dry eyes. Also recommended
    for LASIK dryness*
    30 Single-Use Containers
    0.01 fl oz (0.4 mL) each Sterile

    PRINCIPAL DISPLAY PANEL
NDC 0023-0403-30
Preservative-free
Refresh
Plus
Lubricant Eye Drops
MOISTURIZING RELIEF 
Immediate, soothing relief 
for dry eyes. Also recommended 
for LASIK dryness*
30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH PLUS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-0403
    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
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-0403-055 in 1 CARTON10/09/1996
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:0023-0403-3030 in 1 CARTON10/09/1996
    20.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    3NDC:0023-0403-5050 in 1 CARTON10/09/1996
    30.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    4NDC:0023-0403-7070 in 1 CARTON10/09/1996
    40.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    5NDC:0023-0403-10100 in 1 CARTON10/09/1996
    50.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34910/09/1996
    Labeler - Allergan, Inc. (144796497)