NDC 11716-0002 Goodsense Original Eye Drops

Product Information

What is NDC 11716-0002?

The NDC code 11716-0002 is assigned by the FDA to the product Goodsense Original Eye Drops which is product labeled by Hanlim Pharm. Co., Ltd.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 11716-0002-5 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, RxNorm crosswalk and the complete product label.

NDC Product Code11716-0002
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.		Goodsense Original Eye Drops
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Hanlim Pharm. Co., Ltd.
Labeler Code11716
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.		11-26-2014
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.		12-31-2019
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". 		I
NDC Code Structure

What are the uses for Goodsense Original Eye Drops?


Product Packages

NDC Code 11716-0002-5

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Goodsense Original Eye Drops Active Ingredients UNII Codes

  • TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D)
  • TETRAHYDROZOLINE (UNII: S9U025Y077) (Active Moiety)

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: 1052943 - tetrahydrozoline HCl 0.05 % Ophthalmic Solution
  • RxCUI: 1052943 - tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution
  • RxCUI: 1052943 - tetrahydrozoline hydrochloride 0.05 % Eye Drops
  • RxCUI: 1052943 - tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution

Goodsense Original Eye Drops 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.

* Please review the disclaimer below.

Goodsense Original Eye Drops Product Label

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.

Product Label Table of Contents



Otc - Active Ingredient



Active ingredient                                                  Purpose

Tetrahydrozoline HCL 0.05%................................Redness Reliever


Otc - Purpose



Uses

  • for the relief of redness of the eyes due to minor eye irritations

Warnings



Warnings

Ask a doctor before use if you have narrow angle glaucoma


Otc - When Using



When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Otc - Stop Use



Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition 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 the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.


Indications & Usage



Directions

  • To open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning.
  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor

Storage And Handling



Other information

  • some users may experience a brief tingling sensation
  • store at 15o to 25oC (59o to 77oF)

Dosage & Administration



Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

Made in Korea


Inactive Ingredient



Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate


* Please review the disclaimer below.