NDC 44717-539 Te-fu Recovery Massage

Menthol, Methyl Salicylate

NDC Product Code 44717-539

NDC 44717-539-01

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Te-fu Recovery Massage with NDC 44717-539 is a a human over the counter drug product labeled by Wasatch Product Development. The generic name of Te-fu Recovery Massage is menthol, methyl salicylate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Wasatch Product Development

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Te-fu Recovery 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 5 g/100mL
  • METHYL SALICYLATE 10 g/100mL

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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • STEARYL PHOSPHATE (UNII: F3C8G3904Y)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • GUAR GUM (UNII: E89I1637KE)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CAMPHOR OIL (UNII: 75IZZ8Y727)
  • CLOVE LEAF OIL (UNII: VCA5491KVF)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • C13-15 ALKANE (UNII: 114P5I43UJ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • GINGER OIL (UNII: SAS9Z1SVUK)

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: Wasatch Product Development
Labeler Code: 44717
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: 11-28-2018 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.

Te-fu Recovery Massage Product Label Images

Te-fu Recovery 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

Active ingredient PurposeMenthol (5.0%) Topical AnalgesicMethyl Salicylicate (10%) Topical Analgesic

Otc - Purpose

UsesProvides warming, penetrating pain relief for sore muscles and jointsMay also provide temporary relief of minor aches and pains associated with backache, strains and bruises

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

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 product and consult a physician.

Warnings

WarningsFor external use only.Avoid contact with eyesDo not bandage tightly

Dosage & Administration

DirectionsAdults and children 2 year of age and older apply to affected area not more than 3 to 4 times per dayChildren under 2yrs of age consult a physician.

Inactive Ingredient

Inactive ingredients: Water, Cinnamomium Camphora (Camphor) Bark Oil, Stearyl Alcohol, C13-15 Alkane, Glycerin, Caprylic/capric Triglyceride, Pentylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Eucalyptus Globulus Leaf Oil, Prunus Amygdalus Dulcis( sweet almond) Oil, Microcrystalline Cellulose, Mentha Piperita (peppermint) Oil, Behenyl Alcohol, Stearyl Phosphate, Eugenia Caryophyllus (Clove) Leaf Oil, Hydroxyacetophenone, Zingiber Officinale (ginger) Root Oil, Arnica Montana Flower Extract, Benzyl Alcohol, Cellulose Gum, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum, Sodium Phytate.

* Please review the disclaimer below.