Eye Wash
Purified Water
Mckesson
Human Otc Drug
NDC 68599-1981Eye Wash also known as Purified Water is a human otc drug labeled by 'Mckesson'. National Drug Code (NDC) number for Eye Wash is 68599-1981. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Eye Wash drug includes Water - 98.3 mL/100mL . The currest status of Eye Wash drug is Active.
Drug Information:
| Drug NDC: | 68599-1981 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Eye Wash |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Purified Water |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mckesson |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | WATER - 98.3 mL/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | IRRIGATION
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 2025 |
| 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. |
| Application Number: | NDA022305 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | McKesson
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1151101
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0612479260023
0612479260030
|
| UPC stands for Universal Product Code. |
| UNII: | 059QF0KO0R
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68599-1981-1 | 29.6 mL in 1 BOTTLE, DISPENSING (68599-1981-1) | 01 Apr, 2021 | N/A | No |
| 68599-1981-4 | 118.3 mL in 1 BOTTLE, DISPENSING (68599-1981-4) | 01 Apr, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose eyewash
Product Elements:
Eye wash purified water boric acid sodium borate sodium chloride water water
Indications and Usage:
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
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
Dosage and Administration:
Directions flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.
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
Package Label Principal Display Panel:
1 fl oz ndc 68599-1981-1 mckesson eye wash 98.3% purified water ophthalmic solution | sterile mfr# mck19828 1 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 âtamper evident sealâ ⢠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 28 each 28 case
4 fl oz 68599-1981-4 mckesson eye wash 98.3% purified water ophthalmic solution | sterile mfr# mck19818 4fl 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 âtamper evident sealâ ⢠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 18 each 18 case
Further Questions:
Questions? call 1-800-777-4908