Plus Rinse Emergency Eyewash
Purified Water
Innovative Safety Supply Inc.
Human Otc Drug
NDC 72598-022Plus Rinse Emergency Eyewash also known as Purified Water is a human otc drug labeled by 'Innovative Safety Supply Inc.'. National Drug Code (NDC) number for Plus Rinse Emergency Eyewash is 72598-022. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Plus Rinse Emergency Eyewash drug includes Water - 99.1 mL/100mL . The currest status of Plus Rinse Emergency Eyewash drug is Active.
Drug Information:
| Drug NDC: | 72598-022 |
| 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: | Plus Rinse Emergency Eyewash |
| 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: | Innovative Safety Supply Inc. |
| 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 - 99.1 mL/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 06 May, 2019 |
| 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: | part349 |
| 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: | INNOVATIVE SAFETY SUPPLY INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1053429
|
| 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. |
| 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 |
|---|
| 72598-022-20 | 500 mL in 1 BOTTLE (72598-022-20) | 06 May, 2019 | 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 emergency eyewash
Product Elements:
Plus rinse emergency eyewash purified water sodium chloride water water
Indications and Usage:
Uses for rinsing the eyes to reduce risk of severe injury caused by chemicals or particulate contamination
Warnings:
Warnings for external use only do not use for injection for intraocular surgery internally if solution changes color or becomes cloudy. when using this product avoid contamination do not reuse. once opened, discard. ask a doctor if you have eye pain changes in vision redness or irritation of the eye after use an injury caused by alkali keep out of reach of children if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only do not use for injection for intraocular surgery internally if solution changes color or becomes cloudy. when using this product avoid contamination do not reuse. once opened, discard. ask a doctor if you have eye pain changes in vision redness or irritation of the eye after use an injury caused by alkali keep out of reach of children if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contamination do not reuse. once opened, discard.
General Precautions:
Other information not for use as a contact lens solution do not use after bottle expiration store at room temperature, 5° to 35° c (41° to 95°f)
Dosage and Administration:
Directions do not dilute solution or reuse bottle use only unopened bottle to open, twist cap in the direction of the arrow avoid contamination of the integrated eyecup place integrated eyecup over affected eye(s) tilt head backward open eyelid(s) wide control rate of flow by pressure on bottle thoroughly bathe eye(s) with solution allow solution to flow away from eye(s) rinse until the bottle is empty and continue rinsing with plum emergency eyewash until you reach a doctor continue rinsing with water if necessary obtain medical treatment.
Package Label Principal Display Panel:
Principal display panel ndc : 72598-022-20 plus rinse emergency eyewash compliance: ansi/isea z358.1-2014 (as personal eyewash only) innovative safety supply labeler: innovative safety supply inc, 368 edson st, saskatoon, sk/s7j 0p9/canada. www.plusrinse.com sterile - 500 ml (16.9 fl oz) ndc: 72598-022-01 plus rinse emergency eyewash compliance: ansi/isea z358.1-2014 (as personal eyewash only) innovative safety supply labeler: innovative safety supply inc, 368 edson st, saskatoon, sk/s7j 0p9/canada. www.plusrinse.com sterile - 1000 ml (33.8 fl oz) ndc: 72598-022-02 plus rinse emergency eyewash compliance: ansi/isea z358.1-2014 (as personal eyewash only) innovative safety supply labeler: innovative safety supply inc, 368 edson st, saskatoon, sk/s7j 0p9/canada. www.plusrinse.com sterile - 200 ml (6.8 fl oz) pic1 pic2 pic3
Further Questions:
Questions or comments? call toll-free number 1-844-405-7233