NDC 70000-0522 Eye Itch Relief
Ketotifen Fumarate Solution Ophthalmic

Product Information

Eye Itch Relief is a human over the counter drug product labeled by Cardinal Health. The generic name of Eye Itch Relief is ketotifen fumarate. The product's dosage form is solution and is administered via ophthalmic form.

Product Code70000-0522
Proprietary Name 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.
Eye Itch Relief
Non-Proprietary Name 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.
Ketotifen Fumarate
Product Type 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.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.
Cardinal Health
Labeler Code70000
FDA Application Number 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.
NDA021996
Marketing Category 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.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-07-2020
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Eye Itch Relief?


Product Packages

NDC 70000-0522-1

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

Price per Unit: $1.45648 per ML

NDC 70000-0522-2

Package Description: 1 BOTTLE in 1 CARTON > 10 mL in 1 BOTTLE

Price per Unit: $0.43900 per ML

Product Details

What are Eye Itch Relief Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • KETOTIFEN FUMARATE .25 mg/mL - A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis.

Eye Itch Relief Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 311237 - ketotifen 0.025 % Ophthalmic Solution
  • RxCUI: 311237 - ketotifen 0.25 MG/ML Ophthalmic Solution
  • RxCUI: 311237 - ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution
  • RxCUI: 311237 - ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution

Eye Itch Relief Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Eye Itch Relief Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)


Purpose



Antihistamine


Uses



For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.


Warnings



For external use only

Do not use

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

    • ▪remove contact lenses before use
    • ▪wait at least 10 minutes before re-inserting contact lenses after use
    • ▪do not touch tip of container to any surface to avoid contamination
    • ▪replace cap after each use
    • Stop use and ask a doctor if you experience any of the following:

      • ▪eye pain
      • ▪changes in vision
      • ▪redness of the eyes
      • ▪itching that worsens or lasts for more than 72 hours

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.


Directions



Adults and children 3 years 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



Store at 4-25°C (39-77°F)


Inactive Ingredients



benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection


Questions Or Comments?



[phone icon] Toll Free Product Information
Call: 1-877-758-1480


Package/Label Principal Display Panel



LEADER[heart icon]™

NDC 70000-0522-2

Sterile Eye Drops

Eye Itch
Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS

Up to 12 Hours

Works in Minutes

Original Prescription Strength

For Ages 3 Years and Older

COMPARE TO
ZADITOR®
active ingredient

100% Money
Back Guarantee

0.34 FL OZ (10 mL)


* Please review the disclaimer below.