Eyewash Station Additive Concentrate
Chlorhexidine Gluconate And Propylene Glycol
Acme United Corporation
Human Otc Drug
NDC 0924-0159Eyewash Station Additive Concentrate also known as Chlorhexidine Gluconate And Propylene Glycol is a human otc drug labeled by 'Acme United Corporation'. National Drug Code (NDC) number for Eyewash Station Additive Concentrate is 0924-0159. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Eyewash Station Additive Concentrate drug includes Chlorhexidine Gluconate - 145.6 kg/2800L Propylene Glycol - 280 kg/2800L . The currest status of Eyewash Station Additive Concentrate drug is Active.
Drug Information:
| Drug NDC: | 0924-0159 |
| 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: | Eyewash Station Additive Concentrate |
| 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: | Chlorhexidine Gluconate And Propylene Glycol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Acme United Corporation |
| 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: | CHLORHEXIDINE GLUCONATE - 145.6 kg/2800L
PROPYLENE GLYCOL - 280 kg/2800L
|
| 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 NOT 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: | 09 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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, 2024 |
| 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: | Acme United Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UPC: | 0073577904965
|
| UPC stands for Universal Product Code. |
| UNII: | MOR84MUD8E
6DC9Q167V3
|
| 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. |
| Pharmacologic Class: | Decreased Cell Wall Integrity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0924-0159-08 | .236 L in 1 BOTTLE, UNIT-DOSE (0924-0159-08) | 09 Jan, 2023 | 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 preservative
Product Elements:
Eyewash station additive concentrate chlorhexidine gluconate and propylene glycol water chlorhexidine gluconate chlorhexidine propylene glycol propylene glycol
Indications and Usage:
Use a preservative for use in potable self-contained emergency eyewash stations
Warnings:
Warnings for external use only. in case of contact with eye in undiluted form, flush with clean water do not use in full strength when using this product do not change dilution or use with other chemicals do not reuse stop use and ask a doctor if you have 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.
Do Not Use:
Warnings for external use only. in case of contact with eye in undiluted form, flush with clean water do not use in full strength when using this product do not change dilution or use with other chemicals do not reuse stop use and ask a doctor if you have 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.
When Using:
When using this product do not change dilution or use with other chemicals do not reuse
Dosage and Administration:
Directions wear protective eyewear and gloves clean potable eyewash station and rinse with potable water partially fill station with potable water remove tamper evident seal and cap from bottle add entire contents of the bottle to the eyewash station container fill the station to the manufacturer's required level date and initial inspection tag station should be cleaned and refilled every 120 days when using this product in advance of emergency, add the concentrate to potable water to have a solution available
Package Label Principal Display Panel:
Bottle label bottle label
Further Questions:
Questions ? â call 1.800.835.2263