Advanced Eye Relief/ Redness Maximum Relief
Naphazoline Hydrochloride And Hypromellose
Bausch & Lomb Incorporated
Human Otc Drug
NDC 24208-450Advanced Eye Relief/ Redness Maximum Relief also known as Naphazoline Hydrochloride And Hypromellose is a human otc drug labeled by 'Bausch & Lomb Incorporated'. National Drug Code (NDC) number for Advanced Eye Relief/ Redness Maximum Relief is 24208-450. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Advanced Eye Relief/ Redness Maximum Relief drug includes Hypromellose, Unspecified - 5 mg/mL Naphazoline Hydrochloride - .3 mg/mL . The currest status of Advanced Eye Relief/ Redness Maximum Relief drug is Active.
Drug Information:
| Drug NDC: | 24208-450 |
| 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: | Advanced Eye Relief/ Redness Maximum Relief |
| 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: | Naphazoline Hydrochloride And Hypromellose |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bausch & Lomb Incorporated |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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: | HYPROMELLOSE, UNSPECIFIED - 5 mg/mL
NAPHAZOLINE HYDROCHLORIDE - .3 mg/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: | 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: | 02 Sep, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| 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: | Bausch & Lomb Incorporated
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1046654
|
| 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: | 0310119020685
|
| UPC stands for Universal Product Code. |
| UNII: | 3NXW29V3WO
MZ1131787D
|
| 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 |
|---|
| 24208-450-15 | 1 BOTTLE, DROPPER in 1 CARTON (24208-450-15) / 15 mL in 1 BOTTLE, DROPPER | 02 Sep, 2010 | N/A | No |
| 24208-450-90 | 2 BOTTLE, DROPPER in 1 CARTON (24208-450-90) / 15 mL in 1 BOTTLE, DROPPER | 01 May, 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 lubricant redness reliever
Product Elements:
Advanced eye relief/ redness maximum relief naphazoline hydrochloride and hypromellose hypromellose, unspecified hypromellose, unspecified naphazoline hydrochloride naphazoline benzalkonium chloride boric acid edetate disodium water sodium borate sodium chloride hydrochloric acid sodium hydroxide
Indications and Usage:
Uses ⢠temporary relief of redness and discomfort due to: ⢠minor eye irritations ⢠exposure to wind or sun ⢠dryness of the eye ⢠prevents further irritation
Warnings:
Warnings for external use only do not use ⢠if solution changes color or becomes cloudy ask a doctor before use if you have ⢠narrow angle glaucoma when using this product ⢠do not touch tip of container to any surface to avoid contamination ⢠do not overuse as it may produce increased redness of the eye ⢠pupils may become enlarged temporarily ⢠remove contact lenses before using ⢠replace cap after 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 for more than 72 hours 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 ⢠if solution changes color or becomes cloudy ask a doctor before use if you have ⢠narrow angle glaucoma when using this product ⢠do not touch tip of container to any surface to avoid contamination ⢠do not overuse as it may produce increased redness of the eye ⢠pupils may become enlarged temporarily ⢠remove contact lenses before using ⢠replace cap after 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 for more than 72 hours 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 touch tip of container to any surface to avoid contamination ⢠do not overuse as it may produce increased redness of the eye ⢠pupils may become enlarged temporarily ⢠remove contact lenses before using ⢠replace cap after use
Dosage and Administration:
Directions ⢠instill 1 to 2 drops in the affected eye(s) up to four times daily
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 for more than 72 hours
Package Label Principal Display Panel:
Package/label principal display panel bausch + lomb advanced eye relief ® maximum redness redness reliever/lubricant eye drops ⢠maximum strength redness reliever ⢠moisturizes and comforts sterile 0.5 fl oz (15 ml) 3843901 ab55411a carton
Further Questions:
Questions or comments? [phone icon] call: 1-800-553-5340