Otc - Active Ingredient
Active ingredients
Polyvinyl alcohol.....0.5%
Povidone......0.6%
Good Sense Artificial Tears Solution
FDA Label NDC 50804-110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc. for the product Good Sense Artificial Tears (NDC 50804-110). 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, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Polyvinyl alcohol ...Eye lubricant
Povidone ...Eye lubricant
Indications & Usage
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
Warnings
For external use only
Otc - Do Not Use
Do not use this product if solution changes color or becomes cloudy
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Otc - When Using
When using this product
- to avoid contamination, do not touch tip of container to any surface
- replace cap after using. Keep container tightly closed
- remove contact lens before using
Dosage & Administration
Directions
Instill 1 or 2 drops in the affected eye(s) as needed.
Other Safety Information
Other information
- Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
- RETAIN THIS CARTON FOR FUTURE REFERENCE
- Store at 15°-30° C (59°-86°F)
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic
Package Label.Principal Display Panel
Carton (Goodsensearttears)
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