NDC 11993-000 Astrapharm Chilli Brand

Capsaicin

NDC Product Code 11993-000

NDC 11993-000-01

Package Description: 24 PATCH in 1 PACKAGE > .25 g in 1 PATCH (11993-000-11)

NDC 11993-000-02

Package Description: 50 PACKAGE in 1 PACKAGE > 5 PATCH in 1 PACKAGE (11993-000-12) > .25 g in 1 PATCH

NDC Product Information

Astrapharm Chilli Brand with NDC 11993-000 is a a human over the counter drug product labeled by Dersan Pharmaceutical Co., Ltd. The generic name of Astrapharm Chilli Brand is capsaicin. The product's dosage form is plaster and is administered via topical form.

Labeler Name: Dersan Pharmaceutical Co., Ltd

Dosage Form: Plaster - Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin.

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.

Astrapharm Chilli Brand 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.

  • CAPSAICIN .25 g/100g

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.

  • .BETA.-PINENE (UNII: 4MS8VHZ1HJ)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • NAPHTHA (UNII: O3L624621X)
  • POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
  • NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
  • BROWN IRON OXIDE (UNII: 1N032N7MFO)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

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.
  • 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: Dersan Pharmaceutical Co., Ltd
Labeler Code: 11993
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: 03-01-2020 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.

Astrapharm Chilli Brand 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 Ingredients

Capsaicin 0.25%..............................External analgesic

Otc - Ask Doctor

Stop use and ask doctor if

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Clean and dry affected area, peel plaster away from paper backing and apply to the affected area by pressing edges down firmly.If needed, cut plaster into smaller pieces.Adults and children 12 years of age and over: Apply to affected area not more than 3 times daily. Children under 12 years, consult doctor before use.

Other Information:

  • Once opened, keep the unused plaster in an air-tight container.Store at 20-25°C(68-77°F)

Inactive Ingredients:

Beta-pinene homopolymer, calcium carbonate, light steam-cracked aromatic naphtha(petroleum), polybutenes, rubber(natural), synthetic iron oxide, and zinc oxide

Purpose

External analgesic

Do Not Use

  • On woundsdamaged or irritated skin

When Using This Product

  • Avoid contact with the eyes or mucous membranesdo not bandage tightlymay cause rash or festering. Not recommended for people with sensitive skin.burning sensation may occur. Not recommended for use when in contact with hot water.highly adhesive plaster may hurt skin upon removal of product. Do not apply on hairy surface of skin.

Stop Use And Ask A Doctor If

  • Excessive irritation of the skin developsCondition worsensSymptoms persist for more than 7 daysSymptoms clear up and occur again within a few daysWhen using for pain of arthritis:   if redness is present   in conditions affecting children under 12 years of age

Uses:

  • Temporarily relieves minor aches and pains of muscles and joints due to:simple backachearthritisstrainsbruisessprains

Warnings

For external use only

Astrapharm "Chilli Brand" External Analgesic Plaster 4.5In X 7In

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Inner Package 4.5In X 7In

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Astrapharm "Chilli Brand" External Analgesic Plaster 4.5In X 3.4In

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Inner Package 4.5In X 3.5In

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* Please review the disclaimer below.