NDC 36800-856 Topcare Health Advanced Moisturizing Plus Redness Relief

Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl

NDC Product Code 36800-856

NDC CODE: 36800-856

Proprietary Name: Topcare Health Advanced Moisturizing Plus Redness Relief 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: Dextran 70, Polyethylene Glycol 400, Povidone, 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.

NDC Code Structure

  • 36800 - Topco Associates Llc
    • 36800-856 - Topcare Health Advanced Moisturizing Plus Redness Relief

NDC 36800-856-01

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

NDC Product Information

Topcare Health Advanced Moisturizing Plus Redness Relief with NDC 36800-856 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Health Advanced Moisturizing Plus Redness Relief is dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Topco Associates Llc

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.

Topcare Health Advanced Moisturizing Plus Redness Relief 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.

  • DEXTRAN 70 .1 g/100mL
  • POVIDONE 1 g/100mL
  • TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL
  • POLYETHYLENE GLYCOL 400 1 g/100mL

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

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.
  • 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: Topco Associates Llc
Labeler Code: 36800
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: 02-04-2020 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: 12-31-2021 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 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’.

* Please review the disclaimer below.

Topcare Health Advanced Moisturizing Plus Redness Relief Product Label Images

Topcare Health Advanced Moisturizing Plus Redness Relief 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 ingredientsDextran 70 0.1%Polyethylene glycol 400 1%Povidone 1%Tetrahydrozoline HCl 0.05%

Otc - Purpose

PurposesDextran 70... LubricantPolyethylene glycol 400... LubricantPovidone... LubricantTetrahydrozoline HCl... Redness reliever

Indications & Usage

  • Usesrelieves redness of the eye due to minor eye irritationsas a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

WarningsFor external use only

Otc - Ask Doctor

Ask a doctor before use if you have narrow angle glaucoma

Otc - When Using

  • When using this productpupils may become enlarged temporarilyto avoid contamination, do not touch tip of container to any surface. Replace cap after usingif solution changes color or becomes cloudy, do not useoveruse may produce increased redness of the eyeremove contact lens before using

Otc - Stop Use

  • Stop use and ask a doctor if you experienceeye painchanges in visioncontinued redness or irritation of the eye, or if the condition worsens or persists for 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 reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

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

Other Safety Information

Other informationstore at 15º-30ºC (59º-86ºF)

Inactive Ingredient

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

* Please review the disclaimer below.