Otc - Active Ingredient
Active Ingredients Purposes
Tetrahydrozoline HCl 0.05%.......Eye redness reliever
Zinc sulfate 0.25%......................Eye astringent
Careone Eye Drops Seasonal Relief
FDA Label NDC 41520-653
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foodhold U.s.a Llc for the product Careone Eye Drops Seasonal Relief (NDC 41520-653). 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, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - 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
Otc - Purpose
Uses
- for temporary relief of discomfort and redness of the eye due to minor eye irritations
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
- overuse may cause more eye redness
- remove contact lenses before using
- do not use if this solution changes color or becomes cloudy
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
Otc - Stop 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
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 (1-800-222-1222) right away.
Indications & Usage
Directions
- to open bottle, push cap down and twist counterclockwise
- put 1 to 2 drops in the affected eye(s) up to 4 times daily
- children under 6 years of age: ask a doctor
Storage And Handling
- some users may exprience a brief tingling sensation
- store between 15-25°C (59-77°F)
Inactive Ingredient
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate
Otc - Questions
Questions or comments?
Call 1-877-846-9949
Dosage & Administration
Distributed by:
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
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