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Real eyewash - Medication Information

Product NDC Code 59276-416
Drug Name

Real eyewash

Type Brand
Active Ingredients
Water .983 ml/ml
Route OPHTHALMIC
Dosage Form SOLUTION
RxCUI drug identifier 1151101
Application Number NDA022305
Labeler Name Oliver Landon Intl Inc.
Packages
Package NDC Code Description
59276-416-01 30 ml in 1 bottle, unit-dose (59276-416-01)
59276-416-04 118 ml in 1 bottle, unit-dose (59276-416-04)
59276-416-08 236 ml in 1 bottle, unit-dose (59276-416-08)
59276-416-16 473 ml in 1 bottle, unit-dose (59276-416-16)
59276-416-32 946 ml in 1 bottle, unit-dose (59276-416-32)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Purified water 98.3%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients boric acid, sodium borate, sodium chloride

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Purpose

Information about the drug product’s indications for use.
Purpose Eyewash

Spl product data elements

Usually a list of ingredients in a drug product.
Real Eyewash Eyewash WATER WATER BORIC ACID SODIUM BORATE SODIUM CHLORIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package/Label Principal Display Panel – 1 FL OZ (30 mL) label Real Eyewash 1 FL OZ (30 mL) front label Real Eyewash 1 FL OZ (30 mL) back label Package/Label Principal Display Panel – 4 FL OZ (118 mL) Real Eyewash 4 FL OZ (118 mL) label Package/Label Principal Display Panel – 8 FL OZ (236 mL) Real Eyewash 8 FL OZ (236 mL) label Package/Label Principal Display Panel – 16 FL OZ (473 mL) Real Eyewash 16 FL OZ (473 mL) label Package/Label Principal Display Panel – 32 FL OZ (946 mL) Real Eyewash 32 FL OZ (946 mL) label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other information • lot number is printed on the bottle • store at 20° to 25° C [68° to 77° F) • for your protection, this bottle has an imprinted white seal with black printing “TAMPER EVIDENT SEAL” • do not use if this seal is missing or broken • use before expiration date marked on bottle

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call (800) 839-5929 9 a.m. to 5 p.m. EST Mon-Fri

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Do not use • if you experience any open wounds in or near the eyes and obtain immediate medical treatment • if solution changes color or becomes cloudy When using this product • to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard Stop use and ask a doctor if you have any of the following • changes in vision • eye pain • condition worsens or persists • continued redness or irritation of the eye

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API