NDC 67510-0665 Seasonal Itchy And Red Eye Relief

Tetrahydrozoline Hcl,Zinc Sulfate Liquid Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
67510-0665
Proprietary Name:
Seasonal Itchy And Red Eye Relief
Non-Proprietary Name: [1]
Tetrahydrozoline Hcl, Zinc Sulfate
Substance Name: [2]
Tetrahydrozoline Hydrochloride; Zinc Sulfate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
  • Labeler Name: [5]
    Kareway Product, Inc.
    Labeler Code:
    67510
    FDA Application Number: [6]
    part349
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    11-12-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 67510-0665-1

    Package Description: 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

    NDC Code 67510-0665-5

    Package Description: 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

    Product Details

    What is NDC 67510-0665?

    The NDC code 67510-0665 is assigned by the FDA to the product Seasonal Itchy And Red Eye Relief which is a human over the counter drug product labeled by Kareway Product, Inc.. The generic name of Seasonal Itchy And Red Eye Relief is tetrahydrozoline hcl, zinc sulfate. The product's dosage form is liquid and is administered via ophthalmic form. The product is distributed in 2 packages with assigned NDC codes 67510-0665-1 1 bottle in 1 carton / 30 ml in 1 bottle, 67510-0665-5 1 bottle in 1 carton / 15 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Seasonal Itchy And Red Eye Relief?

    Put 1 to 2 drops in the affected eye(s) up to 4 times dailychildren under 6 years of age:  ask a doctor

    What are Seasonal Itchy And Red Eye 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.
    • TETRAHYDROZOLINE HYDROCHLORIDE .05 mg/mL
    • ZINC SULFATE .25 mg/mL - A compound given in the treatment of conditions associated with zinc deficiency such as acrodermatitis enteropathica. Externally, zinc sulfate is used as an astringent in lotions and eye drops. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)

    Which are Seasonal Itchy And Red Eye Relief UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Seasonal Itchy And Red Eye 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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Seasonal Itchy And Red Eye Relief?

    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: 1043249 - tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution
    • RxCUI: 1043249 - tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic Solution
    • RxCUI: 1043249 - Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic Solution

    Which are the Pharmacologic Classes for Seasonal Itchy And Red Eye Relief?

    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.

    Patient Education

    Tetrahydrozoline Ophthalmic


    Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".