Otc - Active Ingredient
Active ingredients
Propylene glycol....0.6%
Leader Restorative Formula Lubricant Eye Drops Solution/ Drops
FDA Label NDC 70000-0013
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 for the product Leader Restorative Formula Lubricant Eye Drops (NDC 70000-0013). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Propylene glycol............ Lubricant
Indications & Usage
Uses
• for the temporary relief of burning and irritation due to dryness of the eye
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
• if this product changes color
• if you are sensitive to any ingredient in this product
Otc - When Using
When using this product
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use
Otc - Stop Use
Stop use and ask a doctor if
• you experience eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists or lasts 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.
Dosage & Administration
Directions
- Shake well before using.
- Instill 1 or 2 drops in the affected eye(s) as needed
Other Safety Information
Other information
- Store at room temperature.
Inactive Ingredient
Inactive ingredients
Benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Otc - Questions
Questions & comments?
1-888-527-4276
Package Label.Principal Display Panel
Carton-single Pack (Leadresforlub)
Carton-twin Pack (Leadresforlubtw)
* Please review the disclaimer below.
