NDC 24208-537 Lumify Redness Reliever Eye Drops

Brimonidine Tartrate

NDC Product Code 24208-537

NDC CODE: 24208-537

Proprietary Name: Lumify Redness Reliever Eye Drops 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: Brimonidine Tartrate 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat open-angle glaucoma or high fluid pressure in the eye. Lowering high fluid pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This medication lowers pressure by allowing better fluid drainage from within the eye and also by reducing the amount of fluid formed in the eye. It is known as an alpha agonist. This drug is not recommended for use in children less than 2 years of age due to an increased risk of serious side effects such as very slowed breathing. Ask the doctor or pharmacist for details.

NDC Code Structure

NDC 24208-537-01

Package Description: 1 AMPULE in 1 CARTON > .4 mL in 1 AMPULE

NDC 24208-537-05

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 5 mL in 1 BOTTLE, DROPPER

NDC 24208-537-08

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 2.5 mL in 1 BOTTLE, DROPPER

NDC 24208-537-10

Package Description: 1 AMPULE in 1 CARTON > .4 mL in 1 AMPULE

NDC 24208-537-15

Package Description: 2 BOTTLE, DROPPER in 1 CARTON > 7.5 mL in 1 BOTTLE, DROPPER

NDC 24208-537-25

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 7.5 mL in 1 BOTTLE, DROPPER

NDC 24208-537-75

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 7.5 mL in 1 BOTTLE, DROPPER

NDC 24208-537-99

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 2.5 mL in 1 BOTTLE, DROPPER

NDC Product Information

Lumify Redness Reliever Eye Drops with NDC 24208-537 is a a human over the counter drug product labeled by Bausch & Lomb Incorporated. The generic name of Lumify Redness Reliever Eye Drops is brimonidine tartrate. 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.

Lumify Redness Reliever Eye Drops 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.

  • BRIMONIDINE TARTRATE .25 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)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)

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: NDA208144 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: NDA - A product marketed under an approved New Drug Application. 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: 12-22-2017 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Brimonidine Ophthalmic

Brimonidine Ophthalmic is pronounced as (bri moe' ni deen)

Why is brimonidine ophthalmic medication prescribed?
Ophthalmic brimonidine is used to lower pressure in the eyes in patients who have glaucoma (high pressure in the eyes that may damage nerves and cause vision loss) and oc...
[Read More]

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Lumify Redness Reliever Eye Drops Product Label Images

Lumify Redness Reliever Eye Drops 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 Ingredient

Brimonidine tartrate (0.025%)

Purpose

Redness reliever

Use

  • •relieves redness of the eye due to minor eye irritations

Warnings

For external use only

Do Not Use

  • •if solution changes color or becomes cloudy

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 3 days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • •adults and children 5 years of age and over: •instill 1 drop in the affected eye(s) every 6-8 hours •do not use more than 4 times daily •remove contact lenses before use •wait at least 10 minutes before re-inserting contact lenses after use •if using other ophthalmic products while using this product, wait at least 5 minutes between each product •to avoid contamination, do not touch tip of container to any surface •replace cap after each use •children under 5 years of age: consult a doctor

Other Information

  • •store at 15°-25°C (59°-77°F)

Inactive Ingredients

Benzalkonium chloride, boric acid, calcium chloride dihydrate, glycerin, potassium chloride, sodium borate decahydrate, sodium chloride. water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

* Please review the disclaimer below.