NDC 81772-001 Sk Original Eye Drops

Tetrahydrozoline Hcl

NDC Product Code 81772-001

NDC CODE: 81772-001

Proprietary Name: Sk Original Eye Drops 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.

Non-Proprietary Name: Tetrahydrozoline Hcl 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Tetrahydrozoline is a decongestant used to relieve redness in the eyes caused by minor eye irritations (e.g., smog, swimming, dust, or smoke). It belongs to a class of drugs known as sympathomimetic amines. It works by temporarily narrowing the blood vessels in the eye. Some brands of tetrahydrozoline eye drops may contain lubricants. Lubricants help protect the eyes from more irritation and dryness.

NDC Code Structure

  • 81772 - Synpac-kingdom Pharmaceuticals, Co., Ltd.

NDC 81772-001-01

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

NDC Product Information

Sk Original Eye Drops with NDC 81772-001 is a a human over the counter drug product labeled by Synpac-kingdom Pharmaceuticals, Co., Ltd.. The generic name of Sk Original Eye Drops is tetrahydrozoline hcl. The product's dosage form is solution and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1052943.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Sk Original Eye Drops 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.


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.

  • EDETIC ACID (UNII: 9G34HU7RV0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • WATER (UNII: 059QF0KO0R)

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: Synpac-kingdom Pharmaceuticals, Co., Ltd.
Labeler Code: 81772
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: 06-29-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Sk Original Eye Drops Product Label Images

Sk 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 ingredientTetrahydrozoline HCl 0.05%

Otc - Purpose

PurposeTetrahydrozoline HCl......Redness reliever

Indications & Usage

  • Usefor the relief of redness of the eye due to minor eye irritations

Warnings

WarningsFor external use onlyDo 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 productpupils may become enlarged temporarilydo not touch tip of container to any surface to avoid contaminationreplace cap after usingoveruse may produce increased redness of the eye

Otc - Stop Use

  • Stop use and ask a doctor if you experience
  • Eye painchanges in visioncoontinued redness or irritation of the eye, or if the 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.

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration

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

Other Safety Information

  • Other informationStore at room temperatureRemove contact lens before using

Inactive Ingredient

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

* Please review the disclaimer below.