Drugplain

Rohto Cool Max .3 mg/mL

Naphazoline hydrochloride, Polysorbate 80 · LIQUID · The Mentholatum Company

No Recall History
Plain English

Rohto Cool Max is a liquid containing naphazoline hydrochloride, polysorbate 80 at .3 mg/mL, taken ophthalmic. Manufactured by The Mentholatum Company.

Key Facts

Brand Name
Rohto Cool Max
Generic Name
Naphazoline hydrochloride, Polysorbate 80
NDC Code (Product)
10742-8159
Manufacturer
The Mentholatum Company
Strength
.3 mg/mL
Dosage Form
LIQUID
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
05/05/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

eye irritation5 reports
ocular hyperaemia4 reports
off label use3 reports
drug ineffective2 reports
anorectal discomfort1 reports
arthropathy1 reports
asthma1 reports
blindness transient1 reports
burning sensation1 reports
death1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

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 do not store above 25°C (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 top 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.

Frequently Asked Questions

What is Rohto Cool Max used for?

Rohto Cool Max contains Naphazoline hydrochloride, Polysorbate 80. It is a liquid taken ophthalmic. Consult your doctor for specific uses.

Is Rohto Cool Max a controlled substance?

Rohto Cool Max is not classified as a controlled substance by the DEA.

What is the generic name for Rohto Cool Max?

The generic name for Rohto Cool Max is Naphazoline hydrochloride, Polysorbate 80. There are 3 other brand versions of Naphazoline hydrochloride, Polysorbate 80.

What is the NDC code for Rohto Cool Max .3 mg/mL?

The NDC (National Drug Code) for Rohto Cool Max .3 mg/mL is 10742-8159, listed by The Mentholatum Company.

Product NDC

10742-8159

Package NDC

10742-8159-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)