Refresh Optive Solution/ Drops
FDA Label NDC 0023-3416

11 label sections · Submitted to the FDA by Allergan, Inc. · 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 (NDC 0023-3416). 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 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 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

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container. *Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.

Other Information

  • Use only if single-use container is intact.
  • Use before expiration date marked on container.
  • Store at 59°-77°F (15°-25°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?

Phone (Refresh Optive 01)

Phone (Refresh Optive 01)

  1.800.678.1605

refresheyedrops.com

v2.0DFL3416

Principal Display Panel

NDC 0023-3416-30
PRESERVATIVE-FREE
Refresh
OPTIVE®
Lubricant Eye Drops
Dual-Action Relief
For Dry, Sensitive Eyes 
30 Vials 0.01 fl oz (0.4 mL) each Sterile

Principal Display Panelndc 0023-3416-30preservative-freerefreshoptive®lubricant Eye Dropsdual-action Relieffor Dry, Sensitive Eyes 30 Vials 0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Optive 02)

Principal Display Panelndc 0023-3416-30preservative-freerefreshoptive®lubricant Eye Dropsdual-action Relieffor Dry, Sensitive Eyes 30 Vials 0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Optive 02)

* Please review the disclaimer below.