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Drug Facts
Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558
Visine A.c. Itchy Eye Relief Solution/ Drops
FDA Label NDC 69968-0366
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Visine A.c. Itchy Eye Relief (NDC 69968-0366). 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 - purpose, use, warnings, otc - ask doctor, when using this product, stop use and ask a doctor if, 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
| Active ingredients | Purpose |
|---|---|
| Tetrahydrozoline HCl 0.05% | Redness reliever |
| Zinc sulfate 0.25% | Astringent |
Use
- 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.
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
- some users may experience a brief tingling sensation
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 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
- children under 2 years of age: do not use
Other Information
- store at 15° to 25°C (59° to 77°F)
Inactive Ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate
Questions?
call toll-free 888-734-7648 or 215-273-8755 (collect)
Principal Display Panel - 15 Ml Bottle Carton
VISINE®
A.C.
ITCHY EYE RELIEF
ASTRINGENT /
REDNESS RELIEVER EYE DROPS
RELIEVES ITCHY, RED,
WATERY EYES
STERILE
1/2 FL OZ (15mL)
Principal Display Panel (15 mL Bottle Carton)
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