NDC 50488-1060 Capsaicin 0.1 Percent

Capsaicin

NDC Product Code 50488-1060

NDC 50488-1060-6

Package Description: 60 g in 1 BOTTLE

NDC Product Information

Capsaicin 0.1 Percent with NDC 50488-1060 is a a human over the counter drug product labeled by Alexso, Inc. The generic name of Capsaicin 0.1 Percent is capsaicin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Alexso, Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 0.1 Percent 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 .1 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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
  • LAURETH-7 (UNII: Z95S6G8201)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: 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: 02-01-2020 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.

Capsaicin 0.1 Percent 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 0.1%

Purpose

External analgesic

Uses

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

Warnings

For external use onlyRead all warnings and directions before use. Test first on small area of skin.

Do Not Use

• On wounds or damaged skin• If you are allergic to capsicum or chili peppers

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 Doctor If

• Condition worsens or does not improve after regular use• Severe burning persists or blistering occurs

Keep Out Of Reach Of Children.

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

Directions

Adults and children 18 years of age and older:Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily.Children under 18 years: Ask a doctor

Other Information

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

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine

* Please review the disclaimer below.