NDC 36800-641 Topcare Eye Drops

Carboxymethylcellulose Sodium

NDC Product Code 36800-641

NDC 36800-641-65

Package Description: 6 POUCH in 1 CARTON > 5 VIAL, SINGLE-USE in 1 POUCH > .4 mL in 1 VIAL, SINGLE-USE

NDC Product Information

Topcare Eye Drops with NDC 36800-641 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Eye Drops is carboxymethylcellulose sodium. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Topco Associates Llc

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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 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.

  • CARBOXYMETHYLCELLULOSE SODIUM .5 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.

  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

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: 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: 05-31-2019 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: 12-31-2020 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 Eye Drops Product Label Images

Topcare 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

Active Ingredient (In Each Single-Use Container)

Carboxymethylcellulose sodium 0.5%

Purpose

Eye lubricant

Uses

  • •for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun •may be used as a protectant against further irritation

Warnings

For external use only

Do Not Use

If solution changes color or becomes cloudy

When Using This Product

  • To avoid contamination •do not touch tip of container to any surface •do not reuse •once opened, discard •do not touch unit-dose tip to eye

Stop Use And Ask A Doctor If

  • •you experience eye pain •changes in vision occur •redness or irritation of the eye continues •redness or irritation of the eye worsens or persists for more than 72 hours

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • •to open, twist and pull tab to remove •instill 1 or 2 drops in the affected eye(s) as needed and discard container

Other Information

  • •store at 20-25°C (68-77°F) •RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium lactate solution, water for injection. May also contain sodium hydroxide and/or hydrochloric acid to adjust pH.

* Please review the disclaimer below.

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