NDC 11716-0002 Goodsense Original Eye Drops

NDC Product Code 11716-0002

NDC 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.

NDC Product Information

Goodsense Original Eye Drops with NDC 11716-0002 is a product labeled by Hanlim Pharm. Co., Ltd.. The generic name of Goodsense Original Eye Drops is . The product's dosage form is and is administered via form.

Labeler Name: Hanlim Pharm. Co., Ltd.

Dosage Form: -

Product Type: 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.

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)

Product Labeler Information

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

Labeler Name: Hanlim Pharm. Co., Ltd.
Labeler Code: 11716
Start Marketing Date: 11-26-2014 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: 12-31-2019 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: I 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’.

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Information for Patients

Tetrahydrozoline Ophthalmic

Tetrahydrozoline Ophthalmic is pronounced as (tet ra hye droz' a leen)

Why is tetrahydrozoline ophthalmic medication prescribed?
Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming....
[Read More]

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Goodsense Original Eye Drops Product Label Images

Goodsense Original Eye Drops 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 ingredient                                                  PurposeTetrahydrozoline HCL 0.05%................................Redness Reliever

Otc - Purpose

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

Warnings

WarningsAsk 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 cloudyto avoid contamination, do not touch tip of container to any surfacereplace cap after each use

Otc - Stop Use

  • Stop use and ask a doctor if you 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 the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • DirectionsTo 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 dailychildren under 6 years of age: ask a doctor

Storage And Handling

  • Other informationsome users may experience a brief tingling sensationstore at 15o to 25oC (59o to 77oF)

Dosage & Administration

Distributed by:Geiss, Destin & Dunn, Inc.Peachtree City, GA 30269Made in Korea

Inactive Ingredient

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

* Please review the disclaimer below.