NDC 66902-166 Game On Xtreme
Menthol, Unspecified Form Liquid Topical

Product Information

What is NDC 66902-166?

The NDC code 66902-166 is assigned by the FDA to the product Game On Xtreme which is a human over the counter drug product labeled by Natural Essentials Inc.. The generic name of Game On Xtreme is menthol, unspecified form. The product's dosage form is liquid and is administered via topical form. The product is distributed in a single package with assigned NDC code 66902-166-34 96 g in 1 can . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code66902-166
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.		Game On Xtreme
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, Unspecified Form
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 FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.		Natural Essentials Inc.
Labeler Code66902
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.		02-28-2023
Listing Expiration Date 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.		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

What are the uses for Game On Xtreme?


Product Packages

NDC Code 66902-166-34

Package Description: 96 g in 1 CAN

Product Details

What are Game On Xtreme Active Ingredients?

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.

Game On Xtreme Active Ingredients UNII Codes

  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (Active Moiety)

Game On Xtreme Inactive Ingredients UNII Codes

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.

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Game On Xtreme Product Label

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.

Product Label Table of Contents



Active Ingredients



Natural Menthol USP 3.7%


Purpose



Topical analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only

Flammable:

  • Do not use while smoking or near heat or flame

Do Not Apply



  • to wounds or damaged, broken or irritated skin.
  • Do not allow contact with eyes or mucous membranes.

When Using This Product



  • keep out of eyes
  • do not bandage tightly
  • do not use with a heating pad
  • use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than a week

If Pregnant Or Breast-Feeding,



  • ask a health professional before use.

Keep Out Of Reach Of Children And Pets.



  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions



  • shake well
  • adults and children 12 years of age and older:
  • spray product on area not more than 1 to 3 times daily
  • children under 12 years of age
  • ask a doctor

Other Information



May cause staining. Use with caution when spraying near fabric and unprotected surfaces


Inactive Ingredients



Alcohol Denatured, †Aloe Barbadensis Leaf Juice Powder, †Arnica Montana Extract, Camphor, †Ilex Paraguariensis Leaf Extract, Melaleuca Altemifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate (Vitamin E Acetate), Water.


Questions Or Comments



GameonXtreme.com ■ (888)602-7200

†Symbol before the ingredients indicates certified organic.


Principal Display Panel – 96G Can Label



GAME ON

Xtreme™

WARM UP SPRAY

BEFORE YOU PLAY,

USE GAME ON SPRAY

Nt wt 3.4 oz (96 g)

Principal Display Panel – 96g Can Label - gam03 0000 01

Principal Display Panel – 96g Can Label - gam03 0000 01


* Please review the disclaimer below.