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

  • NDC Code(s): 0023-3416-05, 0023-3416-30, 0023-3416-60
  • 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 15, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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. Do not reuse. Once opened, discard.
    • Do not touch unit-dose tip to eye.
    • 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

    To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

    *lf used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions.

  • Other information

    • Use only if single-use container is intact.
    • Use before expiration date marked on container.
    • 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; sodium borate decahydrate; and sodium citrate dihydrate.

  • Questions or comments?

    1.800.678.1605

    refreshbrand.com

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-3416-30

    Preservative-free

    Refresh
    Optive
    ®
    Lubricant Eye Drops

    LONG-LASTING HYDRATION

    Lubricating and hydrating formula
    penetrates the surface to relieve dryness.
    Also recommended for LASIK dryness.*

    30 Single-Use Containers
    0.01 fl oz (0.4 mL) each Sterile

    Carton
  • INGREDIENTS AND APPEARANCE
    REFRESH OPTIVE 
    carboxymethylcellulose sodium, glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-3416
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-3416-055 in 1 CARTON08/22/2008
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:0023-3416-3030 in 1 CARTON08/22/2008
    20.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    3NDC:0023-3416-6060 in 1 CARTON08/22/2008
    30.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34908/22/2008
    Labeler - Allergan, Inc. (144796497)