Label: REFRESH RELIEVA- carboxymethylcellulose sodium, glycerin solution/ drops

  • NDC Code(s): 0023-6630-03, 0023-6630-10
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 July 25, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients

    Carboxymethylcellulose sodium 0.5%

    Glycerin 0.9%

  • Purpose

    Eye lubricant

    Eye lubricant

  • Uses

    • For the temporary relief of burning and irritation due to the dryness of the eye.
    • For the temporary relief of discomfort due to minor irritations of the eye or exposure to the wind or sun.
    • For use as a protectant against further irritation or to relieve dryness of the eye.
    • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
  • 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

    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°-86°F (15°-30°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

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

  • Questions or comments?

    • 1.800.678.1605

    refreshbrand.com

  • PRINCIPAL DISPLAY PANEL

    NEW
    Refresh®
    RELIEVA
    Lubricates and Protects
    0.33 fl oz (10 mL) Sterile

    PRINCIPAL DISPLAY PANEL
NEW
Refresh®
RELIEVA
Lubricates and Protects
0.33 fl oz (10 mL) Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH RELIEVA 
    carboxymethylcellulose sodium, glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-6630
    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)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-6630-101 in 1 CARTON07/22/2019
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-6630-031 in 1 CARTON07/22/2019
    23 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 FINALpart34907/22/2019
    Labeler - Allergan, Inc. (144796497)