NDC 36800-975 Topcare Maximum Redness Relief Eye Drops

Glycerin, Naphazoline Hydrochloride

NDC Product Code 36800-975

NDC CODE: 36800-975

Proprietary Name: Topcare Maximum Redness Relief 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: Glycerin, Naphazoline Hydrochloride 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.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 36800 - Topco Assoc Llc
    • 36800-975 - Topcare Maximum Redness Relief Eye Drops

NDC 36800-975-01

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

NDC Product Information

Topcare Maximum Redness Relief Eye Drops with NDC 36800-975 is a a human over the counter drug product labeled by Topco Assoc Llc. The generic name of Topcare Maximum Redness Relief Eye Drops is glycerin, naphazoline hydrochloride. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Topco Assoc 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 Maximum Redness Relief 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.

  • GLYCERIN .5 g/100mL
  • NAPHAZOLINE HYDROCHLORIDE .03 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.

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

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 Assoc 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 Maximum Redness Relief Eye Drops Product Label Images

Topcare Maximum Redness Relief 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 ingredientsGlycerin.....0.5%Naphazoline hydrochloride....0.03%

Otc - Purpose

PurposeGlycerin..................................LubricantNaphazoline hydrochloride.....Redness reliever

Indications & Usage

  • UsesFor the relief of redness of the eye due to minor eye irritationsFor the temporary relief of burning and irritation due to dryness of the eyeFor use as a protectant against further irritation or dryness of the eye

Warnings

WarningsFor external use only

Otc - Do Not Use

Do 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 productTo avoid contamination, do not touch tip of container to any surfaceReplace cap after usingOveruse may produce increased redness of the eyePupils may become enlarged temporarily

Otc - Stop Use

  • Stop use and ask a doctor ifyou experience eye painyou experience changes in visionyou experience continued redness or irritation of the eyethe 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.

Dosage & Administration

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

Other Safety Information

  • Other informationstore at room temperatureremove contact lenses before usingTamper evident: Do not use this product if imprinted neckband is missing or broken

Inactive Ingredient

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

* Please review the disclaimer below.