Active Ingredient
Polyvinyl alcohol 1.4%
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops Solution/ Drops
FDA Label NDC 0536-1408
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops (NDC 0536-1408). 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 ingredient, purpose, 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
Purpose
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 lenses 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 a Poison Control Center (1-800-222-1222) immediately.
Directions
- instill 1 to 2 drops in the affected eye(s) as needed
Other Information
- keep in a dry place
- store at 15°-25°C (59°-77°F)
- store away from sources of heat or ignition
Inactive Ingredients
benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.
* Please review the disclaimer below.
