GAME ON XTREME- menthol, unspecified form liquid

Game On Xtreme by

Drug Labeling and Warnings

Game On Xtreme by is a Otc medication manufactured, distributed, or labeled by Natural Essentials Inc., NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

GAME ON XTREME 
menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	37 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-166-34	96 g in 1 CAN; Type 0: Not a Combination Product	02/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/28/2023

Labeler - Natural Essentials Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-166)