Drugplain

Clear Eyes Redness Relief 2.5 mg/mL

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

10 Recalls on Record
Plain English

Clear Eyes Redness Relief is a liquid containing naphazoline hydrochloride and glycerin at 2.5 mg/mL, taken ophthalmic. Manufactured by Prestige Brands Holdings, Inc..

Key Facts

Brand Name
Clear Eyes Redness Relief
Generic Name
Naphazoline Hydrochloride and Glycerin
NDC Code (Product)
67172-797
Manufacturer
Prestige Brands Holdings, Inc.
Strength
2.5 mg/mL
Dosage Form
LIQUID
Route
OPHTHALMIC
Marketing Status
Application #
M018
Drug Class
Non-Standardized Chemical Allergen [EPC]
Marketing Start
04/27/2011

Recall History

10 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 II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: 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 II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: 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

ocular hyperaemia4 reports
pain3 reports
vision blurred3 reports
blindness unilateral2 reports
dehydration2 reports
eye irritation2 reports
eye pruritus2 reports
abdominal discomfort1 reports
application site pain1 reports
arthralgia1 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 for the temporary relief of burning and irritation due to dryness of the eye for use as a protectant against further irritation or to relieve 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 to any surface replace cap after using overuse may produce increased redness of the eye pupils may become temporarily enlarged Stop use and 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 Redness Relief used for?

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

Is Clear Eyes Redness Relief a controlled substance?

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

What is the generic name for Clear Eyes Redness Relief?

The generic name for Clear Eyes 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 Redness Relief 2.5 mg/mL?

The NDC (National Drug Code) for Clear Eyes Redness Relief 2.5 mg/mL is 67172-797, listed by Prestige Brands Holdings, Inc..

Product NDC

67172-797

Package NDC

67172-797-01

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

Data from openFDA · Public domain (CC0 1.0)