Refresh Optive Mega-3 Solution/ Drops
FDA Label NDC 0023-7151

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allergan, Inc. for the product Refresh Optive Mega-3 (NDC 0023-7151). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Carboxymethylcellulose sodium 0.5%
Glycerin 1%
Polysorbate 80 0.5%

Purpose

Eye lubricant
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.

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).
  • Store vials in pouch until use.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Boric acid; butylated hydroxyl toluene; castor oil; erythritol; flaxseed oil; levocarnitine; pemulen TR-2; polyoxyl 40 stearate; purified water; sodium hydroxide; trehalose.

Questions Or Comments?

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All trademarks are the property of their respective owners.           

Principal Display Panel

NDC 0023-5773-30

Preservative-free
Refresh
Optive® 
MEGA-3
Lubricant Eye Drops

ENHANCED WITH FLAXSEED OIL

Prevents tear evaporation and restores all

three layers of the tear film damaged by Dry Eye.
30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile

Ndc 0023-5773-30preservative-freerefresh Optive® Mega-3lubricant Eye Drops Enhanced With Flaxseed Oilprevents Tear Evaporation And Restores Allthree Layers Of The Tear Film Damaged By Dry Eye.30 Single-use Containers0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Optive Mega 3 02)

Ndc 0023-5773-30preservative-freerefresh Optive® Mega-3lubricant Eye Drops Enhanced With Flaxseed Oilprevents Tear Evaporation And Restores Allthree Layers Of The Tear Film Damaged By Dry Eye.30 Single-use Containers0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Optive Mega 3 02)

* Please review the disclaimer below.