NDC 11673-100 Target Eye Drops Maximum Redness Relief Eye

Glycerin, Naphazoline Hydrochloride

NDC Product Code 11673-100

NDC Code: 11673-100

Proprietary Name: Target Eye Drops Maximum Redness Relief Eye Additional informationCallout TooltipWhat 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: Glycerin, Naphazoline Hydrochloride Additional informationCallout TooltipWhat 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.


Code Structure
  • 11673 - Target Corporation
    • 11673-100 - Target Eye Drops Maximum Redness Relief Eye

NDC 11673-100-01

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

NDC Product Information

Target Eye Drops Maximum Redness Relief Eye with NDC 11673-100 is a a human over the counter drug product labeled by Target Corporation. The generic name of Target Eye Drops Maximum Redness Relief Eye is glycerin, naphazoline hydrochloride. 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 Additional informationCallout TooltipWhat 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.


Target Eye Drops Maximum Redness Relief Eye Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GLYCERIN 500 mg/100mL
  • NAPHAZOLINE HYDROCHLORIDE 30 mg/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-08-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Target Eye Drops Maximum Redness Relief Eye Product Label Images

Target Eye Drops Maximum Redness Relief Eye 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 ingredientsGlycerin 0.5%Naphazoline hydrochloride 0.03%

Otc - Purpose

​PurposeGlycerin...LubricantNaphazoline hydrochloride...Redness reliever

Indications & Usage

  • UsesFor the relief of redness of the eye due to minor eye irritationsFor the temporary relief of burning and irritation due to dryness of the eyeFor use as a protectant against further irritation or dryness of the eye

Warnings

Warnings For external use only

Otc - Do Not Use

Do not use if solution changes color or becomes cloudy

Otc - Ask Doctor

Ask a doctor before use if you have narrow angle glaucoma

Otc - When Using

  • When using this productTo avoid contamination, do not touch tip of container to any surfaceReplace cap after usingOveruse may produce increased redness of the eyePupils may become enlarged temporarily

Otc - Stop Use

  • Stop use and ask a doctor if you experience eye painyou experience changes in visionyou experience continued redness or irritation of the eyethe condition worsens or persists 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.

Dosage & Administration

DirectionsInstill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Other Safety Information

  • Other informationstore at room temperatureremove contact lenses before usingTamper Evident: Do not use this product if imprinted neckband is missing or broken.

Inactive Ingredient

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

* Please review the disclaimer below.

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