Visine Red Eye Total Comfort Multi-Symptom
Visine Red Eye Total Comfort Multi-Symptom is an FDA drug label for the active ingredient TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM manufactured by Kenvue Brands LLC administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260611.
- Generic name
- TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM
- Manufacturer
- Kenvue Brands LLC
- Product type
- HUMAN OTC DRUG
- Route
- OPHTHALMIC
- Dosage form
- N/A
- NDC
- 69968-0360
- Application
- M018
- Label effective
- 20260611
About this product
Visine Red Eye Total Comfort Multi-Symptom is an FDA-registered drug product whose active ingredient is TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM. It is labelled by Kenvue Brands LLC taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 69968-0360, application M018, label effective 20260611. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM are most often described in connection with: temporary relief, eye due, irritations relieves, exposure wind, protection against. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses for the temporary relief of discomfort and redness of the eye due to minor eye irritations relieves dryness of the eye for the temporary relief of burning and irritation due to exposure to wind or sun for protection against further irritation
Dosage & Administration
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
Warnings
Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma. When using this product some users may experience a brief tingling sensation 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Recall and safety notices
1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0121-2026 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. | Kenvue Brands LLC | Class II | Ongoing | 20251105 |
Frequently asked questions
What is Visine Red Eye Total Comfort Multi-Symptom used for?
Uses for the temporary relief of discomfort and redness of the eye due to minor eye irritations relieves dryness of the eye for the temporary relief of burning and irritation due to exposure to wind or sun for protection against further irritation
Who makes Visine Red Eye Total Comfort Multi-Symptom?
Kenvue Brands LLC is the labeler of record for Visine Red Eye Total Comfort Multi-Symptom.
What form does Visine Red Eye Total Comfort Multi-Symptom come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Visine Red Eye Total Comfort Multi-Symptom prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Visine Red Eye Total Comfort Multi-Symptom been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.