Active Ingredient
Hypromellose 0.7% BP w/v
Focus Pi For Solution
FDA Label NDC 82724-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Covalent Medical for the product Focus Pi (NDC 82724-007). 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, directions for use, inactive ingredient, tamper protection, use, questions, keep out of reach of children, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Directions For Use
- lnstill 1or 2 drops in the affected eye, as needed
Inactive Ingredient
- Benzalkonium Chloride
- Borax
- Boric acid
- EDTA disodium salt
- Potassium chloride
- Purified water
- Sodiumchloride
Tamper Protection
- For your protection a tamper evident ring is attached to the bottlecap
- Upon opening, this will separate from the cap and can be discarded
- Use only if this ring is present and attached when the bottle is first opened
Use
- For use as a lubricant to prevent further irritation or to relieve dryness of the eye
Questions
Keep Out Of Reach Of Children
- If swallowed, get medical help or contact a poison control center right away
Ask Doctor
- If you experience eye pain
- Change in vision
- Continued redness(or) irritation of the eye
- Condition worsens or persists for more than 72 hours
Do Not Use
- If you are sensitive to any ingredient in this product
- If solution changes color or becomes cloudy
Dosage
Instill 1 or 2 drops in the affected eyes as needed
Warnings
For External Use Only
Indications And Usage
For use as a lubricant to prevent further irritaion or to relieve dryness of the eye
Eye Lubricant
Eye Lubricant
Carton Label
Focus (Focus)
* Please review the disclaimer below.
