FDA Label for Artificial Tears
View Indications, Usage & Precautions
Artificial Tears Product Label
The following document was submitted to the FDA by the labeler of this product Nucare Pharmaceuticals,inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
Polyvinyl alcohol.....0.5%
Povidone......0.6%
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
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