COPPERFIXX- capsaicin ointment

CopperFixx by

Drug Labeling and Warnings

CopperFixx by is a Otc medication manufactured, distributed, or labeled by Quest Products, Inc., Fill Tech USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Capsaicin .025%

Purpose

Topical Analgesic

Uses

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose or allergic reaction, seek medical attention or contact a Poison Control Center right away.

Warnings

For external use only. When using this product - use only as directed - do not apply to wounds, damaged, broken or irritated skin - avoid contact with the eyes or mucous membranes - if severe burning occurs, discontinue use - do not expose the treated area to heat or direct sunlight - do not bandage - do not use with heating pad.

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:

• - Apply to affected area
• - Massage into the painful area until thoroughly absorbed
• - Repeat as necessary, but no more than 3 to 4 times daily
• - WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Children 18 years and younger: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water, Cuprum Metallicum, 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, Dimethicone, Butylene Glycol, Sodium Lactate, Hydrolyzed Silk, Silk Amino Acids, 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 - 57g Jar Carton

COPPER FIXX™

PAIN RELIEF CREAM

Penetrating Relief from Copper

• Immediate Pain Relief
• Eases Muscle Stiffness
• Arthritis Pain Relief

Purified with
Capsaicin .025%

Net Wt. 2 FL OZ/57g

INGREDIENTS AND APPEARANCE

COPPERFIXX 
capsaicin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Water (UNII: 059QF0KO0R)
Copper (UNII: 789U1901C5)
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)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Sodium Lactate (UNII: TU7HW0W0QT)
Silk, Acid Hydrolyzed (1000 MW) (UNII: 8549W658QV)
Amino Acids, Silk (UNII: V0L00EX1IA)
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: 68229-500-02	1 in 1 CARTON
1	NDC: 68229-500-01	57 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/01/2016

Labeler - Quest Products, Inc. (075402441)

Establishment
Name	Address	ID/FEI	Business Operations
Fill Tech USA		965596435	MANUFACTURE(68229-500)