Purpose
Lubricant
Silktears Solution/ Drops
FDA Label NDC 85837-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Silktears for the product Silktears (NDC 85837-0001). 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 purpose, dosage and administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage And Administration
Instill 1 to 2 drops in the affected eye(s) as needed.
Warnings
For external use only.
Do not use if solution changes color or becomes cloudy.
When using this product:
- do not touch tip of container to any surface to avoid contamination
- do not reuse
- once opened, discard
Stop use and ask a doctor if you experience:
- eye pain
- changes in vision
- continued redness or irritation
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Inactive ingredients: purified water, Silk-Derived Protein-4 (SDP-4), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic.
Indications & Usage
For the temporary relief of burning and irritation due to dryness of the eye.
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.
Otc - Active Ingredient
Glycerin 0.4% – Lubricant
Package Label.Principal Display Panel
SilkTears 0.4 mL carton (30-count single-use vials)
* Please review the disclaimer below.
