Active Ingredients
Carboxymethylcellulose sodium 0.5%
Leader Lubricant Eye Drops Solution/ Drops
FDA Label NDC 70000-0012
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 Lubricant Eye Drops (NDC 70000-0012). 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, purpose, uses, warnings, do not use this product if, when using this product, stop use and ask a doctor if, 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
Purpose
Lubricant
Uses
- for the temoprary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
- may be used as a protectant against further irritation
Warnings
For external use only
Do Not Use This Product If
- solution changes color or becomes cloudy
When Using This Product
- do not reuse
- once opened, discard
- to avoid contamination, do not touch tip of container to any surface
- do not touch unit-dose tip to eye
Stop Use And Ask A Doctor If
- you experience eye pain
- changes in vision occur
- redness or irritation of the eye continues
- redness or irritation of the eye worsens or persists for more than 72 hours
Keep Out Of The Reach Of Children.
If accidentally swallowed, get medical help or contact a Poison Control Center (1800-222-1222) immediately.
Directions
- to open, twist and pull tab to remove
- instill 1 or 2 drops in the affected eye(s) as needed and discard container
- if used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor's instructions
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 Ingredients
calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride and sodium lactate. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.
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