NDC 24208-450 Advanced Eye Relief/ Redness Maximum Relief

Naphazoline Hydrochloride And Hypromellose

NDC Product Code 24208-450

NDC CODE: 24208-450

Proprietary Name: Advanced Eye Relief/ Redness Maximum Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Naphazoline Hydrochloride And Hypromellose What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 24208-450-15

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC 24208-450-90

Package Description: 2 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Advanced Eye Relief/ Redness Maximum Relief with NDC 24208-450 is a a human over the counter drug product labeled by Bausch & Lomb Incorporated. The generic name of Advanced Eye Relief/ Redness Maximum Relief is naphazoline hydrochloride and hypromellose. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Bausch & Lomb Incorporated

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Advanced Eye Relief/ Redness Maximum Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYPROMELLOSE, UNSPECIFIED 5 mg/mL
  • NAPHAZOLINE HYDROCHLORIDE .3 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bausch & Lomb Incorporated
Labeler Code: 24208
FDA Application Number: part349 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-02-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Advanced Eye Relief/ Redness Maximum Relief Product Label Images

Advanced Eye Relief/ Redness Maximum Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Hypromellose (0.5%)Naphazoline hydrochloride (0.03%)

Purpose

LubricantRedness reliever

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

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.

Directions

  • •instill 1 to 2 drops in the affected eye(s) up to four times daily

Other Information

  • •store at 15°-25°C (59°-77°F) •keep tightly closed •use before expiration date marked on the carton and bottle

Inactive Ingredients

Benzalkonium chloride (0.01%), boric acid, edetate disodium, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

* Please review the disclaimer below.