Label: TERRAFREEZE PAIN RELIEF- menthol,methyl salicylate,histamine dihydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredients

    Menthol 10.00%

    Methyl Salicylate 10.00%

    Histamine DHCl 0.050%

    Purpose

    Topical Analgesic

  • Uses:

    For the temporary relief of minor aches and pains of the muscles and joints associated with arhritis, simple backache, sprains, bruises and strains.

  • Warnings:

    • For External use only
    • Keep out of reach of children. If swallowed, consult physician.
    • Do not apply to wounds or damaged skin.

    When using this product

    • Avoid contact with eyes.  If product gets into eyes, rinse thoroughly with water
    • Do not bandage tightly

    Stop use and ask a doctor if:

    • Rash appears
    • If symptoms persist for more than seven days, discontinue use and consult physician

    If pregnant or breastfeeding,

    ask a healthcare professional before use.

    Keep out of reach of children.

    If swallowed get medical help or contact Poison Control Center right away.

  • Directions

    •   Apply to affected area 3-4 times daily. Adults and children two-years of age or older:
    •   Consult a physician Children under two-years of age:
  • Other Information

    • Store at room temperature with lid closed tightly.
  • Other Ingredients

    Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, AScorbic Acid (Vitamin C), Bosewellia Serrata Extract, Bromelain, Butylene Glycol, C13-14 Isoparaffin, Chamomilla Recutta (Chamomile) Extract, Citric Acid, Curcuma Longa (Turmeric) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Laureth-7, magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Tricedeth-6, Zingiber Officinale (Ginger) Root Extract

  • Questions or Comments?

    (support email address) or Call 1.855.977.0726

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    TERRAFREEZE PAIN RELIEF 
    menthol,methyl salicylate,histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71805-855
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    BROMELAINS (UNII: U182GP2CF3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TURMERIC (UNII: 856YO1Z64F)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    LICORICE (UNII: 61ZBX54883)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    NIACIN (UNII: 2679MF687A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71805-855-001 in 1 BOX10/12/2017
    157 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/12/2017
    Labeler - Beyond Derma, LLC (080699834)
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