Refresh Tears Solution/ Drops
FDA Label NDC 0023-0798

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 Tears (NDC 0023-0798). 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.

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. Replace cap after using.
  • 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

Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

  • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
  • 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; calcium chloride; magnesium chloride; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions Or Comments?

1.800.433.8871

refreshbrand.com

Principal Display Panel

Refresh
Tears®
Lubricating Eye Drops
MOISTURIZING RELIEF
Immediate, soothing
relief for dry eyes
0.5 fl oz (15 mL) Sterile

Principal Display Panelrefreshtears®lubricating Eye Dropsmoisturizing Reliefimmediate, Soothingrelief For Dry Eyes 0.5 Fl Oz (15 mL) Sterile (Refresh Tears 01)

Principal Display Panelrefreshtears®lubricating Eye Dropsmoisturizing Reliefimmediate, Soothingrelief For Dry Eyes 0.5 Fl Oz (15 mL) Sterile (Refresh Tears 01)

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