Drugplain

Clear Eyes Maximum Redness Relief 5 mg/mL

Naphazoline Hydrochloride and Glycerin · LIQUID · Prestige Brands Holdings, Inc.

5 Recalls on Record
Plain English

Clear Eyes Maximum Redness Relief is a liquid containing naphazoline hydrochloride and glycerin at 5 mg/mL, taken ophthalmic. Manufactured by Prestige Brands Holdings, Inc..

Key Facts

Brand Name
Clear Eyes Maximum Redness Relief
Generic Name
Naphazoline Hydrochloride and Glycerin
NDC Code (Product)
67172-696
Manufacturer
Prestige Brands Holdings, Inc.
Strength
5 mg/mL
Dosage Form
LIQUID
Route
OPHTHALMIC
Marketing Status
Application #
M018
Drug Class
Non-Standardized Chemical Allergen [EPC]
Marketing Start
09/01/2010

Recall History

5 Recalls on Record
Class II07/26/2019

Medtech Products, Inc.

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.

TerminatedVoluntary: Firm initiated
Class II07/26/2019

Medtech Products, Inc.

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.

TerminatedVoluntary: Firm initiated
Class II07/26/2019

Medtech Products, Inc.

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.

TerminatedVoluntary: Firm initiated
Class II07/26/2019

Medtech Products, Inc.

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.

TerminatedVoluntary: Firm initiated
Class II07/26/2019

Medtech Products, Inc.

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

instillation site irritation2 reports
psoriatic arthropathy2 reports
vision blurred2 reports
abdominal discomfort1 reports
abdominal pain upper1 reports
administration site pain1 reports
amenorrhoea1 reports
ascites1 reports
blindness unilateral1 reports
bone pain1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the relief of redness of the eye due to minor eye irritations for the temporary relief of burning and irritation due to the dryness of the eye for use as a protectant against further irritation or dryness of the eye

Dosage & Administration

Directions Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Warnings

Warnings For external use only. Do not use if solution changes color or becomes cloudy. Ask a doctor before use if you have narrow angle glaucoma. When using this product to avoid contamination, do not touch tip of container to any surface replace cap after using overuse may produce increased redness of the eye pupils may become temporarily enlarged Stop use & ask a doctor if: you experience eye pain you experience changes in vision you experience continued redness or irritation of the eye the condition worsens or symptoms last for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is Clear Eyes Maximum Redness Relief used for?

Clear Eyes Maximum Redness Relief contains Naphazoline Hydrochloride and Glycerin. It is a liquid taken ophthalmic. Consult your doctor for specific uses.

Is Clear Eyes Maximum Redness Relief a controlled substance?

Clear Eyes Maximum Redness Relief is not classified as a controlled substance by the DEA.

What is the generic name for Clear Eyes Maximum Redness Relief?

The generic name for Clear Eyes Maximum Redness Relief is Naphazoline Hydrochloride and Glycerin. There are 4 other brand versions of Naphazoline Hydrochloride and Glycerin.

What is the NDC code for Clear Eyes Maximum Redness Relief 5 mg/mL?

The NDC (National Drug Code) for Clear Eyes Maximum Redness Relief 5 mg/mL is 67172-696, listed by Prestige Brands Holdings, Inc..

Product NDC

67172-696

Package NDC

67172-696-01

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

Data from openFDA · Public domain (CC0 1.0)