NDC 36800-860 Topcare Cold And Hot Medicated

Menthol

NDC Product Code 36800-860

NDC 36800-860-05

Package Description: 5 PATCH in 1 BOX > 1 PATCH in 1 PATCH

NDC Product Information

Topcare Cold And Hot Medicated with NDC 36800-860 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Cold And Hot Medicated is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Topco Associates Llc

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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 Cold And Hot Medicated 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.

  • MENTHOL 50 mg/1

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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • ALCOHOL (UNII: 3K9958V90M)
  • KAOLIN (UNII: 24H4NWX5CO)
  • TARTARIC ACID (UNII: W4888I119H)
  • DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

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: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-23-2019 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 Cold And Hot Medicated Product Label Images

Topcare Cold And Hot Medicated 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 ingredient PurposeMenthol 5%..................................................Topical analgesic

Otc - Purpose

  • Usestemporarily relieves minor aches and pains of muscles and joints associated with:simple backachearthritisstrainsbruisessprains

Warnings

Warnings For external use only

Otc - Do Not Use

  • Do not useon wounds or damaged skinwith a heating padon a child under 12 years of age with arthritis-like-conditions

Otc - Ask Doctor

Ask a doctor before use if you haveredness over the affected area

Otc - When Using

  • When using this productuse only as directedavoid contact with eyes or mucous membranesdo not bandage tightlydiscontinue use at least 1 hour before a bath or showerdo not use immediately after a bath or shower

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or symptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation occurs

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

Indications & Usage

  • Directionsopen pouch and remove patchcarefully peel off protective backing and apply sticky side to affected areaadults and children 12 years of age and older:do not wear patch for more than 8 hoursapply to affected area no more than 3 times dailychildren under 12 years of age: consult a doctor

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredientsalcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Dosage & Administration

Distributed by: Topco Associates LLCElk Grove Village, IL 60007Made in China

* Please review the disclaimer below.

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