NDC 0065-4274 Pataday Twice A Day Relief

Olopatadine Hydrochloride

NDC Product Code 0065-4274

NDC 0065-4274-01

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

NDC Product Information

Pataday Twice A Day Relief with NDC 0065-4274 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Pataday Twice A Day Relief is olopatadine hydrochloride. 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.

Pataday Twice A Day 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.

  • OLOPATADINE HYDROCHLORIDE 1 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.

  • SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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: NDA020688 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: 02-28-2020 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.

Pataday Twice A Day Relief Product Label Images

Pataday Twice A Day 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

Otc - Purpose

Active IngredientsPurposeOlopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%)Antihistamine and Redness Reliever

Indications & Usage

Use temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

Warnings

WarningsFor external use only

Do Not Use

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

When Using This Product

  • Do not touch tip of container to any surface to avoid contaminationremove contact lenses before usewait at least 10 minutes before reinserting contact lenses after usedo not wear a contact lens if your eye is red

Otc - Stop Use

  • Stop use and ask a doctor if you experience:eye painchanges in visionincreased redness of the eyeitching 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 2 years of age and older:put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per dayif using other ophthalmic products while using this product, wait at least 5 minutes between each productreplace cap after each usechildren under 2 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%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), purified water, and sodium chloride

Questions?

In the U.S., call 1-800-757-9195 or email alcon.medinfo@alcon.comAlcon Laboratories, Inc.6201 South FreewayFort Worth, Texas 76134Country of Origin: JapanNDC: 0065-4274-019017919-1219

* Please review the disclaimer below.