Otc - Active Ingredient
Active ingredient Purpose
Carboxymethylcellulose sodium (0.5%)...............................................................Eye lubricant
Leader Sterile Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5% Single-use Vials 0.4ml 30ct Solution/ Drops
FDA Label NDC 70000-0751
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Sterile Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5% Single-use Vials 0.4ml 30ct (NDC 70000-0751). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, 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 and irritation due to dryness of the eye.
For the temporary relief of discomfort due to minor irritations of the eye or from exposure
to wind or sun.
For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Warnings
Warnings
For use in the eyes only.
Otc - Do Not Use
Do not use if solution changes color or becomes cloudy.
Otc - When Using
When using this product
do not touch tip of container to any surface to avoid contamination.
do not reuse; once opened discard.
Otc - Stop Use
Stop use and ask a doctor if
you experience eye pain, changes in vision, continued redness or irritation of the eye.
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 (1-800-222-1222) 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.
Storage And Handling
Other information
Use only if tamper seal on top and bottom flaps are intact.
Store between 15-30°C (59-86°F). Keep carton for complete product information.
Inactive Ingredient
Inactive ingredients
Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride,
sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Dosage & Administration
Questions or comments?
Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)
*This product is not manufactured or distributed by Allergan, Inc., an AbbVie company, distributor
of Refresh Plus®.
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