GAME ON XTREME- menthol, unspecified form liquid 
Natural Essentials Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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:

Warnings

For external use only

Flammable:

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

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
GAME ON XTREME 
menthol, unspecified form liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-166
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM3.7 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-166-3496 g in 1 CAN; Type 0: Not a Combination Product02/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/28/2023
Labeler - Natural Essentials Inc. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-166)

Revised: 2/2023
Document Id: 7fdcc070-648f-46b7-ba60-8c3f75b6f955
Set id: 5a1b6192-d537-42b3-add8-22c63e7c986c
Version: 1
Effective Time: 20230228
 
Natural Essentials Inc.