REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]

REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]
PDF | XML

NDC 0023-3240-01, 0023-3240-03, 0023-3240-15
Set ID 7f8d88af-fd3b-4138-af61-f24c59ccebd7
Category HUMAN OTC DRUG LABEL
Packager Allergan, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • 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 or becomes cloudy, 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; and sodium citrate dihydrate.

  • Questions or comments?

    1.800.678.1605

    refreshbrand.com

  • PRINCIPAL DISPLAY PANEL

    Refresh
    Optive
    Lubricant Eye Drops
    LONG-LASTING HYDRATION
    Lubricating and hydrating
    formula penetrates the
    surface to relieve dryness
    0.5 fl oz (15 mL) Sterile

    PRINCIPAL DISPLAY PANEL
Refresh
Optive
Lubricant Eye Drops
LONG-LASTING HYDRATION
Lubricating and hydrating
formula penetrates the
surface to relieve dryness
0.5 fl oz (15 mL) Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH OPTIVE 
    carboxymethylcellulose sodium and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-3240
    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 CHLORITE (UNII: G538EBV4VF)  
    SODIUM CHLORATE (UNII: T95DR77GMR)  
    CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-3240-031 in 1 CARTON09/06/2006
    13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-3240-151 in 1 CARTON09/06/2006
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0023-3240-012 in 1 CARTON09/06/2006
    315 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 FINALpart34909/06/2006
    Labeler - Allergan, Inc. (144796497)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allergan Sales, LLC362898611MANUFACTURE(0023-3240)