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Drug Facts
- Tamper evident. Do not use this product if imprinted neckband is missing or broken.
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Eye Drops
FDA Label NDC 0498-0161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Honeywell Safety Products Usa, Inc for the product Eye Drops (NDC 0498-0161). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Tetrahydrozoline HCl 0.05%
Otc - Purpose
Purpose
Redness reliever
Indications & Usage
Uses
relieves redness of the eye due to minor eye irritations
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use if solution changes color or becomes cloudy
Otc - Ask Doctor
Ask a doctor before use if you have narrow angle glaucoma
Otc - When Using
When using this product
- pupils may become enlarged temporarily
- overuse may produce increased redness of the eye
- remove contact lenses before using
- to avoid contamination, do not touch tip of container to any surface
- replace cap after using
Otc - Stop Use
Stop use and ask a doctor if
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- the condition worsens or persists for more than 72 hours
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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) up to four times daily.
Storage And Handling
Other information Store at 15° to 30°C (59° to 86°F)
Inactive Ingredient
Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride
Package Label.Principal Display Panel
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