NDC 66051-236 Eyewash Additive Concentrate

Water And Propylene Glycol Liquid Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
66051-236
Proprietary Name:
Eyewash Additive Concentrate
Non-Proprietary Name: [1]
Water And Propylene Glycol
Substance Name: [2]
Propylene Glycol; Water
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
  • Labeler Name: [5]
    Haws Corporation
    Labeler Code:
    66051
    FDA Application Number: [6]
    M018
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    07-02-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 66051-236-80

    Package Description: .236 L in 1 BOTTLE, UNIT-DOSE

    Product Details

    What is NDC 66051-236?

    The NDC code 66051-236 is assigned by the FDA to the product Eyewash Additive Concentrate which is a human over the counter drug product labeled by Haws Corporation. The generic name of Eyewash Additive Concentrate is water and propylene glycol. The product's dosage form is liquid and is administered via ophthalmic form. The product is distributed in a single package with assigned NDC code 66051-236-80 .236 l in 1 bottle, unit-dose . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Eyewash Additive Concentrate?

    Wear protective eyewear and glovesclean potable eyewash station and rinse with potable waterpartially fill station with potable waterremove tamper evident seal and cap of bottleadd entire contents of the bottle to the eyewash station containerfill the station to the manufacturer’s required leveldate and initial inspection tagstation should be cleaned and refilled every 120 days when using this productin advance of emergency, add the concentrate to potable water to have a solution available

    What are Eyewash Additive Concentrate Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • PROPYLENE GLYCOL 280 kg/2800L - A clear, colorless, viscous organic solvent and diluent used in pharmaceutical preparations.
    • WATER 2374.4 L/2800L - A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

    Which are Eyewash Additive Concentrate UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Eyewash Additive Concentrate Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

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    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".