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Drug Facts
Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558
Visine Red Eye Hydrating Comfort Solution/ Drops
FDA Label NDC 69968-0356
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 Red Eye Hydrating Comfort (NDC 69968-0356). 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, uses, 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 |
|---|---|
| Polyethylene glycol 400 1% | Lubricant |
| Tetrahydrozoline HCl 0.05% | Redness reliever |
Uses
- for the relief of redness of the eye due to minor eye irritations
- for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
- for use as a protectant against further irritation or to relieve dryness of the eye
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
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
- adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day
- children under 6 years of age: consult a doctor
- children under 2 years of age: do not use
Other Information
Store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic
Questions?
call toll-free 888-734-7648 or 215-273-8755 (collect)
Principal Display Panel - 15 Ml Bottle Carton
VISINE®
RED EYE
HYDRATING
COMFORT
LUBRICANT/REDNESS RELIEVER EYE DROPS
WORKS IN 30 SECONDS
Redness + Irritation Relief
Lubricates +
Refreshes
STERILE
1/2 FL OZ (15mL)
Principal Display Panel (15 mL Bottle Carton)
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