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

  • NDC Code(s): 0023-6465-10, 0023-6465-11
  • 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 May 7, 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, 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

    • 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 this carton.
    • *If used for post-operative (e.g., LASIK) dryness and discomfort, 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.
    • 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?

    Telephone number and website

    HOW SUPPLIED: 0.33 fly oz. (10 ml)                         UPC: 3-0023-6465-10-0
    Made in the U.S.A

  • PRINCIPAL DISPLAY PANEL

    Refresh
    Repair
    Repairs and Protects the
    Eye’s Surface; Also Relieves
    LASIK Dryness*
    NEW!
    PRESERVATIVE-FREE
    0.33 fl oz. (10 mL) Sterile

    Refresh
Repair
Repairs and Protects the 
Eye’s Surface; Also Relieves
LASIK Dryness*
NEW!
PRESERVATITVE-FREE
0.33 fl oz (10 mL) Sterile

  • PRINCIPAL DISPLAY PANEL

    Refresh
    Repair
    Repairs and Protects the
    Eye’s Surface; Also Relieves
    LASIK Dryness*
    NEW!
    PRESERVATIVE-FREE
    0.33 fl oz. (10 mL) Sterile
    PROFESSIONAL SAMPLE
    Not for Retail Sale

    Refresh
Repair
Repairs and Protects the 
Eye’s Surface; Also Relieves
LASIK Dryness*
NEW!
PRESERVATIVE-FREE
0.33 fl oz. (10 mL) Sterile
PROFESSIONAL SAMPLE
Not for Retail Sale
 

  • INGREDIENTS AND APPEARANCE
    REFRESH REPAIR PRESERVATIVE-FREE 
    carboxymethylcellulose sodium and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-6465
    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:0023-6465-101 in 1 CARTON05/02/2019
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-6465-111 in 1 CARTON05/02/2019
    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 FINALpart34905/02/2019
    Labeler - Allergan, Inc. (144796497)