Label: REFRESH DIGITAL PF- carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops

  • NDC Code(s): 0023-6954-05, 0023-6954-30
  • 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 November 28, 2022

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  • Active ingredients

    Carboxymethylcellulose sodium 0.5%

    Glycerin 1%

    Polysorbate 80 0.5%

  • Purpose

    Eye lubricant

    Eye lubricant

    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, 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.

  • Other information

    • Use only if single-use container is intact.
    • Use before expiration date marked on container.
    • Store at 59°-77°F (15°-25°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide (to adjust pH).

  • Questions or comments?

    Phone 1.800.678.1605

    refreshbrand.com

    v1.0DFL6954

  • Principal Display Panel

    NDC 0023-6954-30

    Refresh®
    DIGITAL PF
    Lubricant Eye Drops
    For Eye Dryness
    with HydroCell™
    Fast-acting Relief
    That Soothes Your Eyes
    30 Vials (0.01 fl oz (0.4 mL) each Sterile

    Principal Display Panel NDC 0023-6954-30 Refresh® DIGITAL PF Lubricant Eye Drops For Eye Dryness with HydroCell™ Fast-acting Relief That Soothes Your Eyes 30 Vials (0.01 fl oz (0.4 mL) each Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH DIGITAL PF 
    carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-6954
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 mg  in 1 mL
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 805 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ERYTHRITOL (UNII: RA96B954X6)  
    LEVOCARNITINE (UNII: 0G389FZZ9M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-6954-3030 in 1 CARTON08/01/2020
    10.4 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    2NDC:0023-6954-051 in 1 CARTON08/01/2020
    2.40 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/01/2020
    Labeler - Allergan, Inc. (144796497)
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