Label: REFRESH RELIEVA PF XTRA- carboxymethylcellulose sodium and glycerin solution/ drops

  • NDC Code(s): 0023-3782-10, 0023-3782-35, 0023-3782-50
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 1, 2024

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  • Active ingredients

    Carboxymethylcellulose sodium 0.5%
    Glycerin 0.9%

  • Purpose

    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. Replace cap after using.
    • 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

    • Prior to first use, please read the “Instructions For Use” inside this carton.
    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Other information

    • Use only if tape seals on top and bottom flaps are intact.
    • Use before expiration date marked on container.
    • Discard 90 days after opening.
    • Store at 59°-77°F (15°-25°C).
    • RETAIN THIS CARTON AND THE INSERT FOR FUTURE REFERENCE.
  • Inactive ingredients

    Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; sodium citrate dihydrate; sodium hyaluronate; and trehalose. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or comments?

    1.800.678.1605

    refresheyedrops.com

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-3782-10

    New
    PRESERVATIVE-FREE
    Refresh®
    RELIEVA® PF
    Xtra
    Lubricant Eye Drops
    With
    HydroCell®
    Fast-Acting Relief
    Hydrates & Protects
    Dry, Sensitive Eyes
    0.33 fl oz (10 mL) Sterile

    PRINCIPAL DISPLAY PANEL NDC 0023-3782-10 New PRESERVATIVE-FREE Refresh® RELIEVA® PF Xtra Lubricant Eye Drops With HydroCell® Fast-Acting Relief Hydrates & Protects Dry, Sensitive Eyes 0.33 fl oz (10 mL) Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH RELIEVA PF XTRA 
    carboxymethylcellulose sodium and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-3782
    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) GLYCERIN9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    ERYTHRITOL (UNII: RA96B954X6)  
    LEVOCARNITINE (UNII: 0G389FZZ9M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TREHALOSE (UNII: B8WCK70T7I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-3782-101 in 1 CARTON03/01/2024
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-3782-351 in 1 CARTON03/01/2024
    210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0023-3782-501 in 1 CARTON03/01/2024
    33.5 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 DrugM01803/01/2024
    Labeler - Allergan, Inc. (144796497)
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