Label: COPPERFIXX- copper and arnica montana ointment

  • NDC Code(s): 68229-502-01, 68229-502-02
  • Packager: Quest Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
    Cuprum Metallicum 11X HPUSMuscle cramps, spasms
    Arnica Montana 4X HPUSSprains, Pain
  • Uses

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

  • Warnings

    Do not use if seal is broken or missing.

    If symptoms persist for more than 7 days or worsen, contact a licensed health care provider.

    KEEP OUT OF REACH OF CHILDREN. For external use only. If swallowed, contact a Poison Control Center. Do not use on open wounds. Avoid contact with eyes or other mucus membranes. If contact occurs, rinse thoroughly with water.

    Stop use and consult a doctor if

    Condition worsens- symptoms persist for more than 7 days or clear up and occur again within a few days- redness is present- irritation develops. If pregnant or breast- feeding, ask a health professional before use.

  • Directions

    Adults and children over 12 years:

    • Ask a doctor before use in children under 12 years of age.
    • Apply liberally to affected area.
    • Massage gently until completely absorbed.
    • Repeat as needed
    • WASH HANDS WITH SOAP AND WATER AFTER APPLYING
  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Water, Isopropyl Myristate, Cetearyl Alcohol, Behentrimonium Methosulfate, Polysorbate 60, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, , Butylene Glycol, Dimethicone, Vanillyl Butyl Ether, Hydrolyzed Silk, Silk Amino Acids, Sodium Lactate, Tocopherol, Allantoin, Lavandula Angustifolia (Lavender) Oil, Disodium EDTA, Diazolidinyl Urea, Sodium Benzoate, Potassium Sorbate, Citrus Medica Limonum (Lemon) Peel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

  • PRINCIPAL DISPLAY PANEL - 57 g Jar Carton

    COPPER FIXX®

    PAIN RELIEF CREAM

    Powered by Copper

    Heat Technology with Arnica

    • Muscle Pain and Stiffness
    • Joint Inflammation
    • Increases Blood Flow

    Net Wt. 2 FL OZ/57g

    pdp

  • INGREDIENTS AND APPEARANCE
    COPPERFIXX 
    copper and arnica montana ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER11 [hp_X]  in 57 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW, ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA4 [hp_X]  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LEMON OIL (UNII: I9GRO824LL)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68229-502-021 in 1 CARTON01/01/2016
    1NDC:68229-502-0157 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2016
    Labeler - Quest Products, Inc. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(68229-502)
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