NDC 81772-003 Sk Lubricant Eye Drops

Polyethylene Glycol 400, Propylene Glycol

NDC Product Code 81772-003

NDC CODE: 81772-003

Proprietary Name: Sk Lubricant 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: Polyethylene Glycol 400, Propylene Glycol 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.

NDC Code Structure

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

NDC 81772-003-01

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

NDC Product Information

Sk Lubricant Eye Drops with NDC 81772-003 is a a human over the counter drug product labeled by Synpac-kingdom Pharmaceuticals, Co., Ltd.. The generic name of Sk Lubricant Eye Drops is polyethylene glycol 400, propylene glycol. 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: 477589.

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 Lubricant 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.

  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • BORIC ACID (UNII: R57ZHV85D4)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • ZINC CHLORIDE (UNII: 86Q357L16B)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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 Lubricant Eye Drops Product Label Images

Sk Lubricant 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 ingredientsPolyethylene glycol 400 0.4%Propylene glycol 0.3%

Otc - Purpose

Active ingredientsPolyethylene glycol 400.....LubricantPropylene glycol...............Lubricant

Indications & Usage

  • Usefor the temporary relief of burning and irritation due to dryness of the eye

Warnings

WarnngsFor external use only

Otc - Do Not Use

  • Do not useif this product changes color or becomes cloudyif you are sensitive to any ingredient in this product

Otc - When Using

  • When using this productdo not touch the tip of container to any surface to avoid contaminationreplace cap after using

Otc - Stop Use

  • Stop use and ask a doctor if you experienceeye painchanges in vision occurcontinued 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 childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsInstill 1 or 2 drops in the affected eye(s) as needed.

Other Safety Information

  • Other informationStore at room temperature

Inactive Ingredient

Inactive ingredientsBenzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, and zinc chloride

* Please review the disclaimer below.