NDC 59316-003 2 In 1 Relief Value Pack
Menthol Kit

Product Information

Product Code59316-003
Proprietary Name 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.
2 In 1 Relief Value Pack
Non-Proprietary Name 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.
Menthol
Product Type 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.
Human Otc Drug
Dosage FormKit - A packaged collection of related material.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Rb Health (us) Llc
Labeler Code59316
FDA Application Number 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.
part348
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-30-2020
End Marketing Date What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
12-31-2024
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 59316-003-18

Package Description: 1 KIT in 1 KIT * 1 PACKET in 1 POUCH (59316-993-07) > 1 PATCH in 1 PACKET > 9 g in 1 PATCH

Product Details

2 In 1 Relief Value Pack is a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of 2 In 1 Relief Value Pack is menthol. The product's dosage form is kit and is administered via form.


What are 2 In 1 Relief Value Pack Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL (UNII: L7T10EIP3A)
  • MENTHOL (UNII: L7T10EIP3A) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • KAOLIN (UNII: 24H4NWX5CO)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)


* Please review the disclaimer below.

2 In 1 Relief Value Pack Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients



Menthol 5%


Purpose



Cooling Pain Relief


Uses:



Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains


Warnings:



For external use only


Ask A Doctor Before Use If You Have:



Sensitive skin


When Using This Product:



• Use only as directed • Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight


Stop Use And Ask A Doctor If:



You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days


If Pregnant Or Breastfeeding:



Ask a health professional before use


Keep Out Of Reach Of Children:



If accidentally ingested, get medical help or contact a Poison Control Center immediately


Directions



Adults and Children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use
Children under 12 years of age: Consult physician


Inactive Ingredients



Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Diazolidinyl Urea, Dihydroxyaluminum Aminoacetate, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water


Questions Or Comments:



1-800-246-3733


Package Labeling:




* Please review the disclaimer below.