Otc - Active Ingredient
Active ingredients
Polyethylene glycol 400 0.4%
Propylene glycol 0.3%
Leader Preservative-free Ultra Lubricating Eye Drops Solution/ Drops
FDA Label NDC 70000-0501
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 Preservative-free Ultra Lubricating Eye Drops (NDC 70000-0501). 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, pregnancy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Polyethylene glycol 400............. Lubricant
Propylene glycol............ Lubricant
Indications & Usage
Uses
• for the temporary relief of burning and irritation of the eye due to dryness of the eye
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product
Otc - When Using
When using this product
• do not touch the 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 feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours
Pregnancy
If pregnant or breast-feeding, ask a health professional before use.
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
• Instill 1 or 2 drops in the affected eye(s) as needed
Other Safety Information
Other information
- store at 15°-25°C (59°-77°F)
- use only if single-use container is intact
- use before expiration date marked on container
- RETAIN THIS CARTON FOR FUTURE REFERENCE
Inactive Ingredient
Inactive ingredients
boric acid, hypromellose, potassium chloride, purified water, sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.
Otc - Questions
Questions or comments? Call 1-888-527-4276
Package Label.Principal Display Panel
Carton (Leadpresfrultlubsgl)
* Please review the disclaimer below.
