Otc - Active Ingredient
Active ingredients
Glycerin.....0.5%
Naphazoline hydrochloride....0.03%
Topcare Maximum Redness Relief Eye Drops Solution
FDA Label NDC 36800-975
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Assoc Llc for the product Topcare Maximum Redness Relief Eye Drops (NDC 36800-975). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Glycerin..................................Lubricant
Naphazoline hydrochloride.....Redness reliever
Indications & Usage
Uses
- For the relief of redness of the eye due to minor eye irritations
- For the temporary relief of burning and irritation due to dryness of the eye
- For use as a protectant against further irritation or dryness of the eye
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
- To avoid contamination, do not touch tip of container to any surface
- Replace cap after using
- Overuse may produce increased redness of the eye
- Pupils may become enlarged temporarily
Otc - Stop Use
Stop use and ask a doctor if
- you experience eye pain
- you experience changes in vision
- you experience continued redness or irritation of the eye
- the condition worsens or persists for more 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
Inatill 1 or 2 drops in the affected eye(s) up to 4 times daily.
Other Safety Information
Other information
- store at room temperature
- remove contact lenses before using
- Tamper evident: Do not use this product if imprinted neckband is missing or broken
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate
Package Label.Principal Display Panel
Carton (Topcaremaximumrednrelief Cedcm0051tr1)
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