Equate Restore Plus Lubricant Eye
FDA Label NDC 49035-657

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc. for the product Equate Restore Plus Lubricant Eye (NDC 49035-657). 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 otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                    Purpose

Carboxymethylcellulose sodium 0.5%...................................... Eye Lubricant

Otc - Purpose

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

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.

Otc - Stop 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

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.

Storage And Handling

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 Ingredient

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.

Dosage & Administration

Distributed By:

Wal-Mart Stores Inc.

Bentonville, AR 72716

Made in Korea

Package Label.Principal Display Panel

Image Description (6577.3)

Image Description (6577.3)

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