NDC 0065-0530 Eye Stream

Purified Water

  1. Labeler Index
  2. Alcon Laboratories, Inc.
  3. NDC: 0065-0530 Eye Stream

NDC Product Code 0065-0530

NDC CODE: 0065-0530

Proprietary Name: Eye Stream 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

NDC 0065-0530-01

Package Description: 30 mL in 1 BOTTLE

NDC 0065-0530-04

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Eye Stream with NDC 0065-0530 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Eye Stream is purified water. The product's dosage form is solution and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1053173 and 1549855.

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.

Eye Stream 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.

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.
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM ACETATE (UNII: 4550K0SC9B)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

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: Alcon Laboratories, Inc.
Labeler Code: 0065
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: 09-30-1990 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: 12-31-2022 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 - NO 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".

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Eye Stream Product Label Images

Eye Stream 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

Uses

For irrigating the eye to help relieve irritation, discomfort and burning by removing loose foreign material, air pollutants, (smog or pollen), or chlorinated water.

Warnings

For external use onlyObtain immediate medical treatment for all open wounds in or near the eyes.This product is not to be used as a saline solution for rinsing and soaking soft contact lenses.NOT FOR INJECTION OR INTRAOCULAR SURGERY.

Do Not Use

  • If this solution changes color or becomes cloudy.if you are sensitive to any ingredient in this product.

When Using This Product

  • Remove contact lenses before using.to avoid contamination, do not touch tip of container to any surface.replace cap after using

Stop Use And Ask A Doctor If You Experience

  • Eye painchanges in visioncontinued rednessirritation of the eyeif the condition worsens or persists for more than 72 hours

Keep Out Of Reach Of Children

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

Directions

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

Other Information

Store at 8°-27°C (46°-80° F)

Inactive Ingredients

Benzalkonium Chloride 0.013% as a preservative, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Potassium Chloride, Sodium Acetate Trihydrate, Sodium Citrate Dihydrate, Sodium Chloride and Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.  The pH of the solution is in the physiological range.

Questions?

In the U.S., Call [email protected]

* Please review the disclaimer below.