NDC 59899-022 Joint And Muscle Pain

Menthol

NDC Product Code 59899-022

NDC 59899-022-00

Package Description: 85 g in 1 TUBE

NDC Product Information

Joint And Muscle Pain with NDC 59899-022 is a a human over the counter drug product labeled by Shaklee Corporation. The generic name of Joint And Muscle Pain is menthol. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1039690.

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.

Joint And Muscle Pain 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.


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)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ARGININE (UNII: 94ZLA3W45F)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GINGER (UNII: C5529G5JPQ)

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: Shaklee Corporation
Labeler Code: 59899
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: 01-01-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Joint And Muscle Pain Product Label Images

Joint And Muscle Pain 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

Menthol (5%)

Purpose

Topical Analgesic

Uses

  • Provides penetrating temporary relief for minor pain in muscles and joints associated with:BackacheArthritisBruisesSprains

Warnings

For external use only.

Do Not Use

  • With a heating pad. Do not apply to wounds or damaged skin. Do not bandage tightly after use.Avoid contact with eyes.Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

Directions

Adults and children over the age of 2: Apply generously to affected area. Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily.


Children under the age of 2: Do not use; consult a physician.

Inactive Ingredients

Water, Propanediol, Isononyl Isononanoate, Cetearyl Alcohol, Ethylhexyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil 1%, Phenoxyethanol, Stearic Acid, Arginine, Cetearyl Glucoside, Carbomer, Polysorbate 60, Caprylyl Glycol, Xanthan Gum, Tocopherol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Glycerin, Zingiber Officinale (Ginger) Root Extract.

* Please review the disclaimer below.