Real Eyewash
Eyewash
Oliver Landon Intl Inc.
Human Otc Drug
NDC 59276-416Real Eyewash also known as Eyewash is a human otc drug labeled by 'Oliver Landon Intl Inc.'. National Drug Code (NDC) number for Real Eyewash is 59276-416. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Real Eyewash drug includes Water - .983 mL/mL . The currest status of Real Eyewash drug is Active.
Drug Information:
| Drug NDC: | 59276-416 |
| 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: | Real 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: | Eyewash |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Oliver Landon Intl Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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 - .983 mL/mL
|
| 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: | 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: | 30 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | Oliver Landon Intl Inc.
|
| 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. |
| 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 |
|---|
| 59276-416-01 | 30 mL in 1 BOTTLE, UNIT-DOSE (59276-416-01) | 01 Sep, 2015 | N/A | No |
| 59276-416-04 | 118 mL in 1 BOTTLE, UNIT-DOSE (59276-416-04) | 01 Sep, 2015 | N/A | No |
| 59276-416-08 | 236 mL in 1 BOTTLE, UNIT-DOSE (59276-416-08) | 01 Sep, 2015 | N/A | No |
| 59276-416-16 | 473 mL in 1 BOTTLE, UNIT-DOSE (59276-416-16) | 01 Sep, 2015 | N/A | No |
| 59276-416-32 | 946 mL in 1 BOTTLE, UNIT-DOSE (59276-416-32) | 01 Sep, 2015 | 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:
Real eyewash eyewash water water boric acid sodium borate sodium chloride
Indications and Usage:
Use for cleansing the eye to help relieve irritation or burning by removing loose foreign material
Warnings:
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 have any of the following ⢠changes in vision ⢠eye pain ⢠condition worsens or persists ⢠continued redness or irritation of the eye
Dosage and Administration:
Directions flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.
Package Label Principal Display Panel:
Package/label principal display panel â 1 fl oz (30 ml) label real eyewash 1 fl oz (30 ml) front label real eyewash 1 fl oz (30 ml) back label
Package/label principal display panel â 4 fl oz (118 ml) real eyewash 4 fl oz (118 ml) label
Package/label principal display panel â 8 fl oz (236 ml) real eyewash 8 fl oz (236 ml) label
Package/label principal display panel â 16 fl oz (473 ml) real eyewash 16 fl oz (473 ml) label
Package/label principal display panel â 32 fl oz (946 ml) real eyewash 32 fl oz (946 ml) label
Further Questions:
Questions? call (800) 839-5929 9 a.m. to 5 p.m. est mon-fri