Drugplain

Eye Wash 99.05 mL/100mL

water solution · SOLUTION/ DROPS · Kroger Company

10 Recalls on RecordCurrently in Shortage
Plain English

Eye Wash is a solution/ drops containing water solution at 99.05 mL/100mL, taken ophthalmic. Manufactured by Kroger Company.

Key Facts

Brand Name
Eye Wash
Generic Name
water solution
NDC Code (Product)
30142-010
Manufacturer
Kroger Company
Strength
99.05 mL/100mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
01/01/2017

Recall History

10 Recalls on Record
Class II09/02/2016

United Exchange Corporation

Lack of assurance of sterility

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II09/02/2016

United Exchange Corporation

Lack of assurance of sterility

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 II02/16/2017

Sato Pharmaceutical Inc.

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

TerminatedVoluntary: Firm initiated
Class I09/02/2016

United Exchange Corporation

Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses washes the eye to help relieve • irritation • stinging • discomfort • itching • burning by removing • loose foreign material • air pollutants (smog or pollen) • chlorinated water

Dosage & Administration

Directions For use with a nozzle applicator. • flush the affected eye(s) as needed • control the rate of flow of solution by pressure on the bottle • do not touch dropper tip to eye When using an eye cup • rinse the cup with Soothing Eye Wash Solution immediately before each use • avoid contamination of the rim and inside surfaces of the cup • fill the cup half full with Soothing Eye Wash Solution and apply the cup to the affected eye(s), pressing tightly to prevent spillage Other information • store at 15°-25°C (59°-77°F) • keep tightly closed • does not contain thimerosal • enclosed eyecup is sterile if packaging is intact • use before expiration date marked on the carton or bottle Direction for use graphics

Warnings

Warnings For external use only Do not use • if you have open wounds in or near the eyes, and get medical help right away • if solution changes color or becomes cloudy When using this product • remove contact lenses before using • do not touch tip of container to any surface to avoid contamination • replace cap after use Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye • condition worsens or persists Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Eye Wash used for?

Eye Wash contains water solution. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Eye Wash a controlled substance?

Eye Wash is not classified as a controlled substance by the DEA.

What is the generic name for Eye Wash?

The generic name for Eye Wash is water solution. There are 3 other brand versions of water solution.

What is the NDC code for Eye Wash 99.05 mL/100mL?

The NDC (National Drug Code) for Eye Wash 99.05 mL/100mL is 30142-010, listed by Kroger Company.

Product NDC

30142-010

Package NDC

30142-010-18

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

Data from openFDA · Public domain (CC0 1.0)