NDC 50488-2025 Capsaicin

Capsaicin

NDC Product Code 50488-2025

NDC 50488-2025-1

Package Description: 2 POUCH in 1 BOX > 5 PATCH in 1 POUCH > 100 g in 1 PATCH

NDC Product Information

Capsaicin with NDC 50488-2025 is a a human over the counter drug product labeled by Alexso, Inc. The generic name of Capsaicin is capsaicin. The product's dosage form is patch and is administered via topical form.

Labeler Name: Alexso, 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 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.

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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • LEMON OIL (UNII: I9GRO824LL)
  • DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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: Alexso, Inc
Labeler Code: 50488
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: 01-08-2020 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.

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

External analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:• arthritis• simple backache• strains• bruises• sprains

Warnings

For external use only. Use only as directed or as directed by a health care professionalRead all warnings and directions before use. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

Do Not Use

• On wounds, cuts, damaged or infected skin• On eyes, mouth, genitals, or any other mucous membranesAllergy 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:

• If pregnant or breast feeding • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.• If severe burning persists or blistering occurs

Keep Out Of Reach Of Children And Pets.

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

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

Aqua (Deionized Water), Sodium Polyacrylate, Glycerin, Sorbitol, Sodium Cellulose Glycolate, Polysorbate 80, Lemon Oil, Aluminum Glycinate, Eucalyptus Oil, Methylparaben, EDTA Disodium Salt

* Please review the disclaimer below.