NDC 0904-6633 Eye Wash

Purified Water

NDC Product Code 0904-6633

NDC 0904-6633-20

Package Description: 1 BOTTLE in 1 BOX > 118 mL in 1 BOTTLE

NDC Product Information

Eye Wash with NDC 0904-6633 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Eye Wash is purified water. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Major Pharmaceuticals

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 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 99.05 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.

  • BORIC ACID (UNII: R57ZHV85D4)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)

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: Major Pharmaceuticals
Labeler Code: 0904
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: 05-01-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 04-01-2020 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Eye Wash Product Label Images

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 (99.05%)

Purpose

Eyewash

Uses

  • Washes the eye to help relieveirritationstingingdiscomfortitchingby removingloose foreign materialair pollutants (smog or pollen)chlorinated water

Warnings

For external use only

Do Not Use

  • If solution changes color or becomes cloudy

When Using This Product

  • Remove contact lenses before usingdo not touch tip of container to any surface to avoid contaminationreplace cap after use

Stop Use And Ask A Doctor If

  • You experience eye pain, changes in vision, continued redness or irritation of the eyecondition worsens or persistsyou have open wounds in or near the eye. Get medical help right away.

Keep Out Of Reach Of Children.

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

Directions

  • Flush the affected eye(s) as neededcontrol the rate of flow of solution by placing pressure on the bottle

When Using An Eye Cup

  • Rinse the cup with Eye Wash immediately before each useavoid contamination of the rim and inside surfaces of the cupfill the cup half full with Eye Wash and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquidtilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash.rinse the cup with clean water after each use

Other Information

  • Store at room temperature 15° - 25°C (59° - 77°F)keep tightly closed

Inactive Ingredients

Boric acid, sodium borate, sodium chloride, hydrochloric acid PRESERVATIVE ADDED: edetate disodium, polyhexamethylene biguanide

Package Label

NDC 0904-6633-20Compare to the active ingredient in Bausch + Lomb Advanced Eye Relief® Eye Wash*MAJOREYEWASHSTERILE

EYE IRRIGATING

SOLUTION
• ​Cleanses• Refreshes

• Soothes
4 FL OZ (118 mL)

* Please review the disclaimer below.