Label: REFRESH OPTIVE DROPS- carboxymethylcellulose sodium and glycerin solution/ drops

  • NDC Code(s): 0023-5459-02, 0023-5459-10
  • 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 September 15, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Carboxymethylcellulose sodium 1%

    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.

  • Other information

    • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
    • 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; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE (stabilized oxychloro complex); sodium borate ® decahydrate; sodium citrate dihydrate.

  • Questions or comments?

    ☎ 1.800.678.1605

    refreshbrand.com

  • PRINCIPAL DISPLAY PANEL

    Refresh
    Optive®

    GEL DROPS

    Lubricant Eye Gel

    EXTENDED THERAPY

    Quick, soothing coverage
    delivers moisture day or night

    0.33 fl oz (10 mL) Sterile

    Principal Display Panel - 10 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    REFRESH OPTIVE DROPS 
    carboxymethylcellulose sodium and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5459
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium10 mg  in 1 mL
    glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX) glycerin9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium chlorite (UNII: G538EBV4VF)  
    boric acid (UNII: R57ZHV85D4)  
    sodium borate (UNII: 91MBZ8H3QO)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    potassium chloride (UNII: 660YQ98I10)  
    calcium chloride (UNII: M4I0D6VV5M)  
    magnesium chloride (UNII: 02F3473H9O)  
    erythritol (UNII: RA96B954X6)  
    levocarnitine (UNII: 0G389FZZ9M)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5459-101 in 1 CARTON09/30/2015
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-5459-021 in 1 CARTON09/30/2015
    22 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 FINALpart34909/30/2015
    Labeler - Allergan, Inc. (144796497)