Refresh Optive Mega-3 Pf Solution/ Drops
FDA Label NDC 0023-3988

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 Pf (NDC 0023-3988). 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 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. Replace cap after using.
  • If solution changes color, do not use.

Stop Use And Ask 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

  • Prior to first use, please read the “Instructions for Use” inside this carton.
  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

  • Use only if tape seals on top and bottom flaps are intact.
  • Use before expiration date marked on container.
  • Discard 90 days after opening.
  • Store at 59°-77°F (15°-25°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive Ingredients

Boric acid; butylated hydroxyl toluene; carbomer copolymer type A; castor oil; erythritol; flaxseed oil; levocarnitine; polyoxyl 40 stearate; purified water; and trehalose. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments?

1.800.678.1605

refresheyedrops.com

PRESERVATIVE-FREE MULTIDOSE BOTTLE

BUILT-IN DOUBLE LOCKOUT SYSTEM KEEPS DROPS STERILE.

©2024 AbbVie. All rights reserved.
All trademarks are the property of their respective owners.

Distributed by: AbbVie, Inc.,
North Chicago, IL 60064

Product of US

Patented. See abbvie.com/patents

Principal Display Panel

NDC 0023-3988-10

NEW
PRESERVATIVE-FREE

Refresh
OPTIVE
MEGA-3® PF
Lubricant Eye Drops

with Hydrocell®

Fast-Acting Dry Eye Relief

Enhanced With
Flaxseed Oil*

0.33 fl oz (10 mL) Sterile

Principal Display Panelndc 0023-3988-10new Preservative-freerefreshoptivemega-3® Pflubricant Eye Dropswith Hydrocell®fast-acting Dry Eye Reliefenhanced Withflaxseed Oil*0.33 Fl Oz (10 mL) Sterile (Refresh Optive Mega 3 Pf 01)

Principal Display Panelndc 0023-3988-10new Preservative-freerefreshoptivemega-3® Pflubricant Eye Dropswith Hydrocell®fast-acting Dry Eye Reliefenhanced Withflaxseed Oil*0.33 Fl Oz (10 mL) Sterile (Refresh Optive Mega 3 Pf 01)

* Please review the disclaimer below.