Refresh Digital Solution/ Drops
FDA Label NDC 0023-6952

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 Digital (NDC 0023-6952). 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 purpose, uses, warnings, stop use and ask a doctor, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purpose

Carboxymethylcellulose sodium 0.5%............................................................Eye lubricant

Glycerin 1%.....................................................................................................Eye lubricant

Polysorbate 80 0.5% ..................................................................................... Eye lubricant

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye.
  • For the temporary relief of discomfort due to minor irritations of the eye or exposure to wind or sun.
  • For use as a protectant against further irritation or to relieve dryness of the eye.
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

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 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 tape seals on top and bottom flaps are intact.
  • 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; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water;

PURITE® (stabilized oxychloro complex); and sodium hydroxide.

Questions Or Comments?

Phone (Refresh Digital 01)

Phone (Refresh Digital 01)

  1.800.433.8871

refreshbrand.com

HOW SUPPLIED: 0.33 fl oz (10 mL)

Principal Display Panel

Refresh Digital
o.33 fl oz (10 mL) Sterile

Principal Display Panelrefresh Digitalo.33 Fl Oz (10 mL) Sterile (Refresh Digital 02)

Principal Display Panelrefresh Digitalo.33 Fl Oz (10 mL) Sterile (Refresh Digital 02)

* Please review the disclaimer below.