NDC 73016-002 Actibeau Sports Massage

Niacinamide, Adenosine

NDC Product Code 73016-002

NDC Code: 73016-002

Proprietary Name: Actibeau Sports Massage What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Niacinamide, Adenosine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 73016 - Activebeuty Co.,ltd.
    • 73016-002 - Actibeau Sports Massage

NDC 73016-002-02

Package Description: 1 TUBE in 1 CARTON > 120 g in 1 TUBE (73016-002-01)

NDC Product Information

Actibeau Sports Massage with NDC 73016-002 is a a human over the counter drug product labeled by Activebeuty Co.,ltd.. The generic name of Actibeau Sports Massage is niacinamide, adenosine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Activebeuty Co.,ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.


Actibeau Sports Massage 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, UNSPECIFIED FORM 4.2 g/120g
  • CAMPHOR (SYNTHETIC) .6 g/120g

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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Activebeuty Co.,ltd.
Labeler Code: 73016
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: 04-01-2019 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.

Actibeau Sports Massage Product Label Images

Actibeau Sports Massage 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

Menthol 3.5%Camphor 0.5%

Otc - Purpose

Topical Analgesic

Indications & Usage

For temporary relief of minor aches and pains of


muscles and joints associated with • simple backache • arthritis • strains• bruises • sprains

Dosage & Administration

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily, Children under two-years of age: consult a physician.

Warnings

For external use only


Flammable keep away from fire or flameWhen using this product, • avoid contact with eyes or mucous membranes • do not bandage tightly • do not apply to wound or damaged or irritated skinStop use and consult a doctor if • condition worsens • symptoms persist for more than 7 days • clear up and occur again within a few days


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

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive Ingredient

Water, Isopropyl Alcohol, Glycerin, Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane, Carbomer, PEG-60 Hydrogenated Caster Oil, Methylparaben, Sodium Hydroxide, FD&C blue No. 1, Flavoring

* Please review the disclaimer below.

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