NDC 36800-702 Topcare Calamine

Calamine 8% And Zinc Oxide 8% Lotion

NDC Product Code 36800-702

NDC Code: 36800-702

Proprietary Name: Topcare Calamine 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: Calamine 8% And Zinc Oxide 8% Lotion 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
    • 36800-702 - Topcare Calamine

NDC 36800-702-96

Package Description: 177 mL in 1 CONTAINER

NDC Product Information

Topcare Calamine with NDC 36800-702 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Calamine is calamine 8% and zinc oxide 8% lotion. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Topco Associates Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Calamine 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.

  • ZINC OXIDE 160 mg/mL

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.

  • BENTONITE (UNII: A3N5ZCN45C)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • WATER (UNII: 059QF0KO0R)
  • CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

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: part347 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: 07-16-2019 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 Calamine Product Label Images

Topcare Calamine 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

Calamine 8% and Zinc Oxide 8%

Otc - Purpose

Skin protectant

Indications & Usage

Dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Warnings

For external use only. Use only as directed.Avoid contact with eyes and mucous membranes.Ask a doctor before using on chilren 6 months of age.

Otc - Keep Out Of Reach Of Children

In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

Dosage & Administration

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.Children under 6 months of age: Consult a doctor before use.

Inactive Ingredient

Bentonite magma, calcium hydroxide, glycerin, purified water.

* Please review the disclaimer below.

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