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OTC products · Product label record

Rohto Max Strength drug information

NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80
The Mentholatum Company · OPHTHALMIC

Product NDC: 10742-8158

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80
Labeler / manufacturerThe Mentholatum Company
RouteOPHTHALMIC
Drug classDrug class not supplied in source label
Product NDC10742-8158
Label effective date2026-08-20

Official product label reference

Rohto Max Strength — The Mentholatum Company

This page contains 11 source sections for NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80, ophthalmic route. Label set e4b49550-1ca3-4bd7-854d-409b53fa5e26, version 7.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses relieves redness of the eye due to minor eye irritations temporarily relieves burning and irritation due to dryness of the eye for protection against further irritation

Purpose

Purpose Naphazoline hydrochloride - Redness reliever Polysorbate 80 - Lubricant
Dosage and administration — label text
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 and precautions
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
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.
Active ingredient
Active ingredients Naphazoline hydrochloride 0.03% Polysorbate 80 0.2%
Ask a doctor before use
Ask a doctor before use if you have narrow angle glaucoma
When to stop use and seek help
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
Child safety
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive ingredient
Inactive ingredients alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, potassium aspartate, purified water, sodium borate
Questions
Questions? 1-877-636-2677 MON-FRI 9 AM - 5 PM (EST)

Official sources and product identifiers

Substances listed: NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80

RxNorm identifiers: 1535485

Package NDC codes

10742-8158-1, 10742-8158-2

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.