NDC 72598-022 Plus Rinse Emergency Eyewash

Purified Water

NDC Product Code 72598-022

NDC Code: 72598-022

Proprietary Name: Plus Rinse Emergency Eyewash What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Purified Water What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72598 - Innovative Safety Supply Inc.
    • 72598-022 - Plus Rinse Emergency Eyewash

NDC 72598-022-20

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Plus Rinse Emergency Eyewash with NDC 72598-022 is a a human over the counter drug product labeled by Innovative Safety Supply Inc.. The generic name of Plus Rinse Emergency Eyewash is purified water. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Innovative Safety Supply Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Plus Rinse Emergency Eyewash Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • WATER 99.1 mL/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Innovative Safety Supply Inc.
Labeler Code: 72598
FDA Application Number: part349 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-06-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Plus Rinse Emergency Eyewash Product Label Images

Plus Rinse Emergency Eyewash Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Purified water 99.1%

Purpose

Emergency eyewash

Uses

For rinsing the eyes to reduce risk of severe injury caused by chemicals or particulate contamination

Warnings

For external use only

Do Not Use

  • For injectionfor intraocular surgeryinternallyIf solution changes color or becomes cloudy.

When Using This Product

  • Avoid contaminationdo not reuse. Once opened, discard.

Ask A Doctor If You Have

  • Eye painchanges in visionredness or irritation of the eye after usean injury caused by alkali

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Do not dilute solution or reuse bottleuse only unopened bottleto open, twist cap in the direction of the arrowavoid contamination of the integrated eyecupplace integrated eyecup over affected eye(s)tilt head backwardopen eyelid(s) widecontrol rate of flow by pressure on bottle  thoroughly bathe eye(s) with solutionallow solution to flow away from eye(s)rinse until the bottle is empty and continue rinsing with Plum Emergency Eyewash until you reach a doctorcontinue rinsing with water if necessaryobtain medical treatment.

Other Information

  • Not for use as a contact lens solutiondo not use after bottle expirationstore at room temperature, 5° to 35° C (41° to 95°F)

Inactive Ingredients

Sterile Sodium Chloride

Imported And Distributed By

Innovative Safety Supply USA Inc., 5150 West 76th St, Indianapolis, IN, 46268

* Please review the disclaimer below.

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