NDC 0498-0101 Eyesaline Emergency Eyewash Concentrate

Water

NDC Product Information

Eyesaline Emergency Eyewash Concentrate with NDC 0498-0101 is a a human over the counter drug product labeled by Honeywell Safety Products Usa, Inc. The generic name of Eyesaline Emergency Eyewash Concentrate is water. The product's dosage form is concentrate and is administered via ophthalmic form.

Labeler Name: Honeywell Safety Products Usa, Inc

Dosage Form: Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.

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.

Eyesaline Emergency Eyewash Concentrate 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 70 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 PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

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.
  • 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: Honeywell Safety Products Usa, Inc
Labeler Code: 0498
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-05-2020 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: 12-31-2021 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.

Eyesaline Emergency Eyewash Concentrate Product Label Images

Eyesaline Emergency Eyewash Concentrate 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (before dilution)Purified Water 70%

Otc - Purpose

PurposeEmergency eyewash

Indications & Usage

Usesfor flushing the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination

Warnings

WarningsFor external use only.

Otc - Do Not Use

  • Do not usein concentrated formwhile wearing contact lensesif solution changes color or becomes cloudyfor injectionin intraocular surgeryinternallyif eye is lacerated or object is embedded

Otc - Ask Doctor

  • Ask a doctor if you haveeye painchanges in visionreddness or irritation of the eye after usean injury caused by an alkali

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsprepare sufficient quantity of constituted eyewash solution in advance of an emergencywhen preparing solution, wear protective eyewear and gloves and follow sanitary proceduresprepare eyewash solution by diluting 1 part concentrate to 60 parts of potable water as follows:measure 1/3 of required amount of potable water into mixing container of eyewash unitto this, add 1/3 of required amount of concentrateagitate or mix thoroughly​repeat two more times until required amount of solution is prepareddiscard prepared solution after 6 months

Storage And Handling

Other information do not freeze

Inactive Ingredient

Inactive ingredients benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Otc - Questions

Questions? Call
1-800-430-5490

* Please review the disclaimer below.