Otc - Active Ingredient
Active ingredients
Hypromellose USP 2.5% w/v .....Lubricant
Vista Gonio Eye Lubricant Solution
FDA Label NDC 77790-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Red Wedding Llc for the product Vista Gonio Eye Lubricant (NDC 77790-022). 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, use, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Indications & Usage
Uses
- for use as a lubricant to prevent further irritation
- to relieve dryness of the eye
Warnings
Warnngs
For external use only
Do not use
■ if this product changes color or becomes cloudy
■ if seal is broken or punctured
When using this product
■ do not touch tip of container to any surface to avoid contamination
■ replace cap after each use
Stop use and consult a physician if you experience any of the following
■ eye pain
■ changes in vision
■ irritation or redness for longer than 72 hours
If pregnant or breast-feeding, ask a health professional before use.
Otc - Do Not Use
Do not use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
Otc - When Using
When using this product
- do not touch the tip of container to any surface to avoid contamination
- replace cap after each use
Otc - Stop Use
Stop use and consult a physician if you experience any of the following:
- eye pain
- changes in vision occur
- irritation or redness for longer than 72 hours
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
Dosage & Administration
Directions
- Instill 1 or 2 drops in the affected eye(s) as needed
Other Safety Information
Other information
- Store at room temperature 15-30 0C(59-86 0 F).
- do not freeze.
- See box for complete information
Inactive Ingredient
Inactive ingredients
Edetate Disodium, Boric Acid, Sodium Borate, Potassium Chloride, Hydrochloric Acid and/or Sodium Hxydroxide may be added to adjust pH, Water for Injection. Preservative - Benzalkonium Chloride NF.
Questions?
In the US Call 1-866-999-1497
Website: www.VistaOTC.com
Package Label.Principal Display Panel
Vista Gonio - Box
Vista Gonio - Label
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