FDA Label for Avitears
View Indications, Usage & Precautions
Avitears Product Label
The following document was submitted to the FDA by the labeler of this product Pinnacle Science, Llc. 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.
Active Ingredient
Polysorbate 80, 1%
Purpose
Lubricant
Uses
- Temporary relief of discomfort, burning and irritation due to dryness of the eye or from exposure to wind, sun, computer use, environmental conditions, prescription medication, post-surgical dry eye or systemically induced dry eye.
- Lubricant and protectant from further irritation
Warnings
- For external use only
- To avoid contamination replace cap after use
- Do not touch the tip of the container to any surface to avoid contamination
- Do not use if solution changes color or becomes cloudy
Stop Use And Ask A Doctor
- If you experience eye pain, changes in vision, continued redness or irritation, or if condition persists for more than 72 hours or worsens
- Keep this and all other drugs out of the reach of children
Directions
- Instill one or two drops in the affected eye(s) as needed
Other Information
Store at 20 to 25° C (68 to 77° F)
Controlled USP Room Temperature
Inactive Ingredients
Citric acid, edetate disodium, WFI water, sodium chloride and the antioxidants: mannitol, pyruvate, retinyl palmitate and sodium citrate.
Principal Display Panel 10Ml Bottle Label
AvitearsTM
Lubrication Eye Drops
0.33 FL.OZ
(10mL)
Maximum Strength for Dry Eyes
Principal Display Panel 10Ml Carton Label
Sterile
AvitearsTM
Lubrication Eye Drops
.33 FL.OZ
(10mL)
No Preservatives
Antioxidant Based
Maximum Strength for Dry Eyes
Principal Display Panel 15Ml Bottle Label
AvitearsTM
Lubrication Eye Drops
0.5 FL.OZ
(15mL)
Maximum Strength for Dry Eyes
Principal Display Panel 15Ml Carton Label
Sterile
AvitearsTM
Lubrication Eye Drops
.5 FL.OZ
(15mL)
No Preservatives
Antioxidant Based
Maximum Strength for Dry Eyes
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