Label: X-TREME FREEZE- cold therapy gel gel

  • NDC Code(s): 67777-144-10, 67777-144-11, 67777-144-20, 67777-144-21, view more
    67777-144-40, 67777-144-41, 67777-144-70, 67777-144-71
  • Packager: Dynarex Corporation
  • 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 March 2, 2023

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  • Active Ingredient

    Menthol USP 4% Active

  • Purpose

    Cooling Pain Relief

  • Use(s)

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

  • Warnings

    For External Use Only

    Flammable:

    Keep away from excessive heat or open flame.

    Ask a doctor before use if you have

    sensitive skin

    When using this product:

    • 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 or if excessive irritation develops
    • Do not bandage
    • Wash hands after use with cool water
    • Do not use with heating pad or device

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days

    If pregnant or breast feeding:

    Ask a health professional before use.

    Keep out of reach of children

    If swallowed, get medical help, contact a physician or Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 2 years of age or older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
    • Children under 2 years of age: Consult physician befor use
  • Other Information

    • Store in a cool dry place

    • Tamper evident. Do not use if seal is damaged.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Certerii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leaf), Camphor, Carbomer, Glycerin, Llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, Tocopheryl Acetate, Triethanolamine

  • Questions?

    1-888-DYNAREX Monday-Friday, 9AM-5PM EST

  • 1441 Label

    1441_BX_MASTER

  • 1442 Label

    1442_IN_MASTER

  • 1444 Label

    1444_IN_MASTER

  • 1447 Label

    1447_IN MASTER

  • INGREDIENTS AND APPEARANCE
    X-TREME FREEZE 
    cold therapy gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-144-10200 in 1 CASE08/17/2018
    1NDC:67777-144-11100 in 1 BOX
    13 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-144-2024 in 1 CASE08/17/2018
    2NDC:67777-144-21118 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-144-4012 in 1 CASE08/17/2018
    3NDC:67777-144-41473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:67777-144-702 in 1 CASE08/17/2018
    4NDC:67777-144-713785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/17/2018
    Labeler - Dynarex Corporation (008124539)
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