Active Ingredients
Polyvinyl alcohol 0.5%
Povidone 0.6%
Leader Artificial Tears 15 Ml Solution/ Drops
FDA Label NDC 70000-0011
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 Artificial Tears 15 Ml (NDC 70000-0011). 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 active ingredients, purposes, uses, warnings, do not use this product if, when using this product, stop use and ask a doctor if you experience, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Lubricant
Lubricant
Uses
- for use as a protectant against further irritation or to relieve dryness of the eye
- for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
Warnings
For external use only
Do Not Use This Product If
- solution changes color or becomes cloudy
When Using This Product
- remove contact lens before using
- to avoid contamination, do not touch tip of container to any surface
- replace cap after using. Keep container tightly closed.
Stop Use And Ask A Doctor If You Experience
- eye pain
- changes in vision
- continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours
Keep Out Of The Reach Of Children.
if accidentally swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.
Directions
- instill 1 or 2 drops in the affected eye(s) as needed
- children under 6 years of age: ask a doctor
Other Information
- store at 15°-30°C (59°-86°F)
Inactive Ingredients
benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic
Questions Or Comments?
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