COPPERFIXX- copper and arnica montana ointment

CopperFixx by

Drug Labeling and Warnings

CopperFixx by is a Homeopathic medication manufactured, distributed, or labeled by Quest Products, Inc., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Cuprum Metallicum 11X HPUS	Muscle cramps, spasms
Arnica Montana 4X HPUS	Sprains, 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 18 years or older:

• 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.

Comments and Questions

1-800-650-0113

PRINCIPAL DISPLAY PANEL - 57 g Jar Carton

COPPER FIXX™

PAIN RELIEF CREAM
Powered by Copper

• Muscle Pain and Stiffness
• Joint Inflammation
  NEW HEAT TECHNOLOGY WITH ARNICA

Net Wt. 2 FL OZ/57g

INGREDIENTS AND APPEARANCE

COPPERFIXX 
copper and arnica montana ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5)	Copper	11 [hp_X]  in 57 g
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW, Arnica Montana Root - UNII:MUE8Y11327)	Arnica Montana	4 [hp_X]  in 57 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68229-502-02	1 in 1 CARTON	01/01/2016
1	NDC: 68229-502-01	57 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		01/01/2016

Labeler - Quest Products, Inc. (075402441)

Establishment
Name	Address	ID/FEI	Business Operations
Fill Tech USA		965596435	MANUFACTURE(68229-502)