NDC 68599-1981 Eye Wash

Purified Water

NDC Product Code 68599-1981

NDC 68599-1981-1

Package Description: 29.6 mL in 1 BOTTLE, DISPENSING

NDC 68599-1981-4

Package Description: 118.3 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Eye Wash with NDC 68599-1981 is a a human over the counter drug product labeled by Mckesson. The generic name of Eye Wash is purified water. The product's dosage form is liquid and is administered via irrigation form.

Labeler Name: Mckesson

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.

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 98.3 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Irrigation - Administration to bathe or flush open wounds or body cavities.

Product Labeler Information

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

Labeler Name: Mckesson
Labeler Code: 68599
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: 04-01-2021 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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

Other

Drug Facts

Otc - Active Ingredient

Drug Facts
Active ingredient

Purified water 98.3%

Otc - Purpose

Purpose Eyewash

Indications & Usage

For external use onlyDo not use
• if you experience any open wounds in or near the eyes and get medical help right away

• if solution changes color or becomes cloudy
When using this product
• to avoid contamination, do not touch tip of container to any surface

• do not reuse

• once opened, discard

Warnings

Warnings
For external use only

Do not use

• if you experience any open wounds in or near the eyes and get medical help right away

• if solution changes color or becomes cloudy

Otc - Stop Use

Stop use and ask a doctor if you experience
• eye pain

• changes in vision

• continued redness or irritation of the eye

• condition worsens or persists

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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

Other Safety Information

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 broken

• use before expiration date marked on bottle

• lot number is printed on the bottle

• store at 20º to 25ºC (68º to 77ºF)

Inactive Ingredient

Inactive ingredients
boric acid, sodium borate, sodium chloride

Otc - Questions

Questions? Call 1-800-777-4908

1 Fl Oz

NDC 68599-1981-1McKessonEye Wash98.3% PURIFIED WATER

OPHTHALMIC SOLUTION | STERILE
MFR# MCK198281 fl oz

(29.6 mL)
Distributed by

McKesson Medical-Surgical Inc.

Richmond, VA 23233

PVN A0221

Made in Canada

1 fl oz eye wash solution

Drug Facts

Active ingredient Purpose

Purified water 98.3% Eyewash

Use

For cleansing the eye to remove loose foreign material

Warnings

For external use only

Do not use

• if you experience any open wounds in or near the eyes and get medical help right away

• if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface

• do not reuse

• once opened, discard

Stop use and ask a doctor if you experience

• eye pain

• changes in vision

• continued redness or irritation of the eye

• condition worsens or persists

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

• 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 broken

• use before expiration date marked on bottle

• lot number is printed on the bottle

• store at 20º to 25ºC (68º to 77ºF)

Inactive ingredients

boric acid, sodium borate, sodium chloride

Questions? Call 1-800-777-4908

4 Fl Oz

68599-1981-4McKessonEye Wash98.3% PURIFIED WATER

OPHTHALMIC SOLUTION | STERILE
MFR# MCK198184fl oz(118.3mL)Distributed by

McKesson Medical-Surgical Inc.

Richmond, VA 23233

PVN A0221

Made in Canada

4 fl oz eye wash solution

Drug Facts

Drug Facts

Active ingredient Purpose

Purified water 98.3% Eyewash

Use

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

Warnings

For external use only

Do not use

• if you experience any open wounds in or near the eyes and obtain immediate medical treatment

• if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface

• do not reuse

• once opened, discard

Stop use and ask a doctor if you experience

• changes in vision

• eye pain

• condition worsens or persists

• continued redness or irritation of the eye

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

• lot number is printed on the bottle

• store at 20º to 25ºC (68º to 77ºF)

• 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 broken

• use before expiration date marked on bottle

Inactive ingredients

boric acid, sodium borate, sodium chloride

Questions? Call 1-800-777-4908

* Please review the disclaimer below.