Rohto Digi-Eye
Rohto Digi-Eye is an FDA drug label for the active ingredient HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE manufactured by The Mentholatum Company 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 20260603.
- Generic name
- HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE
- Manufacturer
- The Mentholatum Company
- Product type
- HUMAN OTC DRUG
- Route
- OPHTHALMIC
- Dosage form
- N/A
- NDC
- 10742-8175
- Application
- M018
- Label effective
- 20260603
About this product
Rohto Digi-Eye is an FDA-registered drug product whose active ingredient is HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE. It is labelled by The Mentholatum Company taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 10742-8175, application M018, label effective 20260603. 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 HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, irritation due, minor eye. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses temporarily relieves burning and irritation due to dryness of the eye relieves redness of the eye due to minor eye irritations
Dosage & Administration
Directions put 1 or 2 drops in the affected eye(s) up to 4 times daily tightly snap on cap to seal Other information store at 20-25°C (68-77°F)
Warnings
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.
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-1541-2020 | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8 | The Mentholatum Company | Class III | Terminated | 20200902 |
Frequently asked questions
What is Rohto Digi-Eye used for?
Uses temporarily relieves burning and irritation due to dryness of the eye relieves redness of the eye due to minor eye irritations
Who makes Rohto Digi-Eye?
The Mentholatum Company is the labeler of record for Rohto Digi-Eye.
What form does Rohto Digi-Eye 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 Digi-Eye 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 Digi-Eye 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.