NDC 11673-672 Up And Up Ultra Itchy Relief

Tetrahydrozoline Hci And Zinc Sulfate

NDC Product Code 11673-672

NDC 11673-672-05

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

NDC Product Information

Up And Up Ultra Itchy Relief with NDC 11673-672 is a a human over the counter drug product labeled by Target Corporation. The generic name of Up And Up Ultra Itchy Relief is tetrahydrozoline hci and zinc sulfate. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Target Corporation

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.

Up And Up Ultra Itchy 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.

  • TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL
  • ZINC SULFATE 2.5 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 CITRATE (UNII: 1Q73Q2JULR)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: Target Corporation
Labeler Code: 11673
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: 09-20-2019 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: 12-31-2020 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.

Up And Up Ultra Itchy Relief Product Label Images

Up And Up Ultra Itchy 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 - Active Ingredient

Active ingredients PurposesTetrahydrozoline HCI 0.05%.................................Eye redness relieverZinc Sulfate 0.25%................................................Eye astringent

Otc - Purpose

  • Usesfor temporary relief of discomfort and redness of the eye due to minor eye irritations

Warnings

WarningsFor external use only

Otc - Ask Doctor

Ask a doctor before use if you have narrow angle glaucoma.

Otc - When Using

  • When using this productpupils may become enlarged temporarilyoveruse may cause more eye rednessremove contact lenses before usingdo not use if this solution changes color or becomes cloudydo not touch tip of container to any surface to avoid contaminationreplace cap after each use

Otc - Stop Use

  • Stop use and ask a doctor ifyou feel eye painchanges in vision occurredness or irritation of the eye lastscondition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

  • Directions to open bottle, push cap down and twist counterclockwiseput 1 to 2 drops in the affected eye(s) up to 4 times dailychildren under 6 years of age: ask a doctor

Storage And Handling

  • Other informationsome users may experience a brief tingling sensationstore between 15-25°C (59-77°F)

Inactive Ingredient

Inactive ingredientsbenzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

Dosage & Administration

Distributed byTarget CorporationMinneapolis, MN 55403Made in Korea

* Please review the disclaimer below.