NDC 78641-786 Eyewash

Eyewash

NDC Product Code 78641-786

NDC 78641-786-67

Package Description: 473 mL in 1 BOTTLE, UNIT-DOSE

NDC 78641-786-68

Package Description: 946 mL in 1 BOTTLE, UNIT-DOSE

NDC Product Information

Eyewash with NDC 78641-786 is a a human over the counter drug product labeled by Global Equipment Company. The generic name of Eyewash is eyewash. The product's dosage form is solution and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1151101.

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.

Eyewash 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.

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

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: Global Equipment Company
Labeler Code: 78641
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: 06-17-2021 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".

* Please review the disclaimer below.

Eyewash 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

Eyewash

Warnings

  • For external use onlyDo not useif you experience any open wounds in or near the eyes and obtain immediate medical treatmentif solution changes color or becomes cloudyWhen using this productto avoid contamination, do not touch tip of container to any surfacedo not reuseonce opened, discard

For external use only

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Stop Use And Ask A Doctor If You Have Any Of The Following

  • Continued redness or irritation of the eyecondition worsens or persistseye painchanges in vision

Keep Out Of Reach Of Children

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

Directions

  • Remove tamper evident seal and capavoid contamination of rim and inside surfaces of the nozzleplace nozzle to the affected area and tilt the bottle to pour liquid out through the nozzleopen eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Other Information

  • Lot number is printed on the bottlestore at 20° to 25° C [68° to 77° F]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 bottle

Inactive Ingredients

Boric acid, sodium borate, sodium chloride

Questions?

☎ Call 905-690-6277 9 a.m. to 5 p.m. EST Mon-Fri

Dosage And Administration

  • Remove tamper evident seal and capavoid contamination of rim and inside surfaces of the nozzleplace nozzle to the affected area and tilt the bottle to pour liquid out through the nozzleopen eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

* Please review the disclaimer below.