X-TREME FREEZE (COLD THERAPY GEL) GEL [DYNAREX CORPORATION]

  • Home
  • X-TREME FREEZE (COLD THERAPY GEL) GEL [DYNAREX CORPORATION]

X-TREME FREEZE (COLD THERAPY GEL) GEL [DYNAREX CORPORATION]
PDF | XML
NDC 67777-144-10, 67777-144-20, 67777-144-40, 67777-144-70
Set ID 79f0802f-03ad-bf8f-e053-2991aa0ae4b5
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • Active Ingredient

    Menthol USP 4% Active

  • Purpose

    Cooling Pain Relief

  • Use

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

    If swallowed, get medical help, contact a physician or Poison Control Center 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
  • Other Information

    Store in a cool dry place

  • 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, Ilex 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

  • Label 1441

    1441 Primary Display Panel

  • Label 1442

    1442 Primary Display Panel

  • Label 1444

    1444 Primary Display Panel

  • Label 1447

    1447 Primary Display Panel

  • 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 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-144-10200 in 1 CASE08/17/2018
    1100 in 1 BOX
    12.88 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-144-2024 in 1 CASE08/17/2018
    2113.28 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-144-4012 in 1 CASE08/17/2018
    3454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:67777-144-702 in 1 CASE08/17/2018
    43633.6 g 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)
View All Sections

Related Drugs

Search DailyMed Drugs