NDC 73408-936 Crane Safety Eye Wash

Water Solution

NDC Product Information

Crane Safety Eye Wash with NDC 73408-936 is a a human over the counter drug product labeled by Crane Safety Llc. The generic name of Crane Safety Eye Wash is water solution. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Crane Safety Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Crane Safety Eye Wash 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 .983 mg/mL

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 BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BORIC ACID (UNII: R57ZHV85D4)

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: Crane Safety Llc
Labeler Code: 73408
FDA Application Number: NDA022305 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: NDA - A product marketed under an approved New Drug Application. 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: 02-03-2020 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.

Crane Safety Eye Wash Product Label Images

Crane Safety Eye Wash 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 98.3%

Purpose

Eye wash

Uses

For cleansing the eye to remove loose foreign material and to also releive irritation and burning.

Warnings

For external use only

Do Not Use

  • If you experience any open wounds in or near the eyes and get medical help right awayif solution changes color or becomes cloudy

When Using This Product

  • To avoid contamination, do not touch tip of container to any surfacedo not reuseonce opened, discard

Stop Use And Ask A Doctor If

  • You experienceeye painchanges in visioncontinued redness or irritation of the eyecondition worsens or persists

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other Information

  • 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 brokenuse before expiration date marked on bottlelot number is printed on the bottlestore at 20º to 25º C [68º to 77º F]

Inactive Ingredients

Boric acid, sodium borate, sodium chloride

Crane Safety Eye Wash Label

EyewashPurified Water, 98.3%Ophthalmic Solution4 Fl oz (118 mL)Single Use Sterile SolutionNDC 63408-936-18Distributed by Crane SafetyMade in CanadaProduct CS93618CRANE Safety®

* Please review the disclaimer below.