Otc - Active Ingredient
Active ingredients Purpose
Mineral oil 42.5%........................................................ Eye Lubricant
White petrolatum 57.3%............................................. Eye Lubricant
Leader Lubricant Eye
FDA Label NDC 70000-0513
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leader for the product Leader Lubricant Eye (NDC 70000-0513). 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 or 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.
- Keep tube tightly closed.
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 right away at 1-800-222-1222.
Indications & Usage
Directions
• Wash your hands.
• Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.
Storage And Handling
Other information
- store away from heat
- protect from freezing
- use before expiration date on the tube
- store at 59°-86° (15°-30°)
Inactive Ingredient
Inactive ingredient
lanolin alcohol
Dosage & Administration
Directions
• Wash your hands.
• Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.
Package Label.Principal Display Panel
Leader Lubricant Eye Ointment
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