NDC 79643-002 Capsaicin

Capsaicin

NDC Product Code 79643-002

NDC 79643-002-01

Package Description: 10 PATCH in 1 BOX > 100 g in 1 PATCH

NDC Product Information

Capsaicin with NDC 79643-002 is a a human prescription drug product labeled by Pharmacure, Inc.. The generic name of Capsaicin is capsaicin. The product's dosage form is patch and is administered via topical form.

Labeler Name: Pharmacure, Inc.

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 Prescription 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.

Capsaicin 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 .025 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.

  • MYRRH (UNII: JC71GJ1F3L)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmacure, Inc.
Labeler Code: 79643
Marketing Category: UNAPPROVED DRUG OTHER - 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: 02-02-2021 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: 12-31-2022 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.

Capsaicin Product Label Images

Capsaicin 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

Capsaicin 0.025%

Purpose

Topical Anesthetic

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises.

Warnings

For external use only. Use only as directed or as directed by a health care professional.


Do not use:• On wounds, cuts, damaged or infected skin.• On eyes, mouth, genitals, or any other mucous membranes.Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.


When using this product:• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this      sensation generally disappears after several days.• Avoid contact with the eyes, lips, nose and mucous membranes.• Do not tightly wrap or bandage the treated area.• Do not apply heat to the treated area immediately before or after use.Stop use and ask a physician:


• rash, itching or excessive skin irritation develops.


• conditions worsen.


• symptoms persist for more than 7 days.


• symptoms clear up and occur again within a few days.


If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children And Pets

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

Directions

Adults and children 18 years of age and older:


 Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. INSTRUCTIONS FOR USE :


Clean and dry the affected area.  Open pouch and remove one patch.  Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.Wash hands with soap and water after handling the patches.  Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.  Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets       cannot get to them. Children under 18 years: Ask a physician

Inactive Ingredients

Adhesive, myrrh gum, zinc oxide.

Other Information

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

* Please review the disclaimer below.