Refresh Plus Solution/ Drops
FDA Label NDC 0023-0403

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 Plus (NDC 0023-0403). 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 ingredient, 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 Ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

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.

*If used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions.

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).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Calcium chloride; magnesium chloride; potassium chloride; purified water; sodium chloride; and sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions Or Comments?

1.800.433.8871

refreshbrand.com

Principal Display Panel

NDC 0023-0403-30
Preservative-free
Refresh
Plus
Lubricant Eye Drops
MOISTURIZING RELIEF 
Immediate, soothing relief
for dry eyes. Also recommended
for LASIK dryness*
30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile

Principal Display Panelndc 0023-0403-30preservative-freerefreshpluslubricant Eye Dropsmoisturizing Relief Immediate, Soothing Relief For Dry Eyes. Also Recommended For Lasik Dryness*30 Single-use Containers0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Plus 01)

Principal Display Panelndc 0023-0403-30preservative-freerefreshpluslubricant Eye Dropsmoisturizing Relief Immediate, Soothing Relief For Dry Eyes. Also Recommended For Lasik Dryness*30 Single-use Containers0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Plus 01)

NDC 0023-0403-30
Preservative-free
Refresh
Plus
Lubricant Eye Drops
MOISTURIZING RELIEF
Immediate, soothing relief
for dry eyes. Also recommended
for LASIK dryness*
30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile

Principal Display Panelndc 0023-0403-30preservative-freerefreshpluslubricant Eye Dropsmoisturizing Relief Immediate, Soothing Relief For Dry Eyes. Also Recommended For Lasik Dryness*30 Single-use Containers0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Plus 02)

Principal Display Panelndc 0023-0403-30preservative-freerefreshpluslubricant Eye Dropsmoisturizing Relief Immediate, Soothing Relief For Dry Eyes. Also Recommended For Lasik Dryness*30 Single-use Containers0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Plus 02)

* Please review the disclaimer below.