Label: GAME ON XTREME- menthol, unspecified form liquid

  • NDC Code(s): 66902-166-34
  • Packager: Natural Essentials Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 28, 2023

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  • 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
  • INGREDIENTS AND APPEARANCE
    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)
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