Active Ingredient
Dextran 70 0.1%
Polyethylene Glycol 400 1%
Povidone 1%
Tetrahydrozoline HCl 0.5%
Optimis7
FDA Label NDC 58697-064
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pacific Health Collaborative, Inc. for the product Optimis7 (NDC 58697-064). 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, purpose, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Purpose
Lubricant
Lubricant
Lubricant
Redness reliever
Use
- for the relief of redness of the eye due to minor eye irritations
- for use as a protectant against further irritation or to relieve dryness of the eye
Warnings
Ask a doctor before use if you have narrow angle glaucoma
When Using This Product
- pupils may become enlarged temporarily
- overuse may cause more eye redness
- remove contact lenses before using
- do not use if this solution changes color or become cloudy
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
Stop Use And Ask A Doctor If
- you feel eye pain
- changes in vision occur
- redness or irritation of the eye lasts
- condition worsens or lasts more than 72 hours
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Put 1 to 2 drops in the affected eye(s) up to 4 times daily
- children under 6 years of age: ask a doctor
Other Information
store between 15° to 25°C (59°F to 77°F)
Inactive Ingredients
boric acid, sodium borate, edetate disodium, benzalkonium chloride, sodium chloride, dilite hydrochloric acid, sterile purified water
Package Label
Optimis7
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