Otc - Active Ingredient
Active ingredient Purpose
Carboxymethylcellulose sodium 0.5%.........................Eye lubricant
Restore Plus Single Vial
FDA Label NDC 65923-657
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Restore Plus Single Vial (NDC 65923-657). 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 - 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 eyes.
- 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 in the condtion 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 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
Single (Single)
* Please review the disclaimer below.
