Otc - Active Ingredient
Active ingredients
Tetrahydrozoline HCl....0.05%
Zinc sulfate.....0.25%
Signature Care Eye Drops A.c. Solution
FDA Label NDC 21130-755
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc for the product Signature Care Eye Drops A.c. (NDC 21130-755). 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 - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Tetrahydrozoline HCl......Redness reliever
Zinc sulfate......Astringent
Indications & Usage
Use
- for temporary relief of discomfort and redness of the eye due to minor eye irritation
Warnings
Warnings
For external use only
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
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using
- if solution changes color or becomes cloudy, do not use
- overuse may produce increased redness of the eye
- remove contact lens before 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, or if 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 to 2 drops in the affected eye(s) up to 4 times daily.
Other Safety Information
Other information
store at 15°-30°C (59°-86°F)
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate
Package Label.Principal Display Panel
Box (Signaturecareeyedropsac Cedac0051sw2)
* Please review the disclaimer below.
