Rohto Cool Relief

Rohto Cool Relief is an FDA-registered drug product whose active ingredient is NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80. It is labelled by The Mentholatum Company taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 10742-8141, application M018, label effective 20260619. 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.

Across FDA labelling, products containing NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 are most often described in connection with: relieves redness, eye due, lubricant prevent, irritation relieve, protection against. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses relieves redness of the eye due to minor eye irritations for use as a lubricant to prevent further irritation or to relieve dryness of the eye for protection against further irritation

Directions put 1 or 2 drops in the affected eye(s) up to 4 times daily tightly snap on cap to seal Other information do not store above 25°C (77°F)

Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use do not use if solution changes color or becomes cloudy overuse may cause more eye redness pupils may become enlarged temporarily remove contact lenses before using Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eyes lasts condition worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

What is Rohto Cool Relief used for?
Uses relieves redness of the eye due to minor eye irritations for use as a lubricant to prevent further irritation or to relieve dryness of the eye for protection against further irritation

Who makes Rohto Cool Relief?
The Mentholatum Company is the labeler of record for Rohto Cool Relief.

What form does Rohto Cool Relief 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 Rohto Cool Relief 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 Rohto Cool Relief 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.