NDC 0065-4011 Zaditor

Ketotifen Fumarate

NDC Product Code 0065-4011

NDC CODE: 0065-4011

Proprietary Name: Zaditor 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: Ketotifen Fumarate 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 prevent and treat itching of the eyes caused by allergies (allergic/seasonal conjunctivitis). Ketotifen is an antihistamine for the eye that treats allergic symptoms by blocking a certain natural substance (histamine). It is also a mast cell stabilizer that prevents allergic reactions by reducing the release of natural substances that cause an allergic reaction.

NDC Code Structure

NDC 0065-4011-05

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

NDC 0065-4011-06

Package Description: 2 BOTTLE, DROPPER in 1 CARTON > 5 mL in 1 BOTTLE, DROPPER

NDC 0065-4011-11

Package Description: 3 BOTTLE, DROPPER in 1 CARTON > 5 mL in 1 BOTTLE, DROPPER

NDC Product Information

Zaditor with NDC 0065-4011 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Zaditor is ketotifen fumarate. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Zaditor 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.

  • KETOTIFEN FUMARATE .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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • 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.
  • 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: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: ANDA077200 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: ANDA - A product marketed under an approved Abbreviated 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: 12-21-2012 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’.

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Information for Patients

Ketotifen Ophthalmic

Ketotifen Ophthalmic is pronounced as (kee toe tye' fen)

Why is ketotifen ophthalmic medication prescribed?
Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a s...
[Read More]

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Zaditor Product Label Images

Zaditor 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

Otc - Purpose

Active ingredientPurposeKetotifen (0.025%)(equivalent to ketotifen fumarate 0.035%)Antihistamine

Indications & Usage

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

For external use only

Do Not Use

  • If solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation

When Using This Product

  • Do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use

Otc - Stop Use

  • Stop use and ask a doctor if you experience any of the following:eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours

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 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor

Other Information

  • Only for use in the eye. Store between 4°-25°C (39°-77°F).

Inactive Ingredients

Benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid

Questions?

Call toll-free1-800-757-9195MedInfo@Alcon.com www.zaditor.comSerious side effects associated with use of this product may be reported to this number.

* Please review the disclaimer below.