Label: REFRESH RELIEVA PRESERVATIVE FREE- carboxymethylcellulose sodium and glycerin solution/ drops

  • NDC Code(s): 0023-6634-01, 0023-6634-10
  • 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 July 3, 2019

If you are a consumer or patient 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 the 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.
    • Prior to first use, bottle must be primed. Please read the “Instructions for Use” on the insert inside of this carton.
    • *If used for dryness and discomfort associated with LASIK, follow your eye doctor’s instructions. 
  • 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 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; and sodium hyaluronate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or comments?

    Refreshbrand.com

    UPC: 3-0023-6465-10-0

    HOW SUPPLIED: 0.33 fly oz. (10 ml)
    Made in the U.S.A

  • PRINCIPAL DISPLAY PANEL

    Refresh
    Relieva PF
    Lubricates and protects
    Also relieves
    LASIK Dryness
    NEW
    PRESERVATIVE-FREE
    0.33 fl oz. (10 mL) Sterile

    PRINCIPAL DISPLAY PANEL
Refresh
Relieva PF
Lubricates and protects
Also relieves
LASIK Dryness
NEW
PRESERVATIVE-FREE
0.33 fl oz. (10 mL) Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH RELIEVA PRESERVATIVE FREE 
    carboxymethylcellulose sodium and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-6634
    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)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-6634-101 in 1 CARTON07/26/2019
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-6634-011 in 1 CARTON07/26/2019
    210 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 FINALpart34907/26/2019
    Labeler - Allergan, Inc. (144796497)