COPPERFIXX- capsaicin ointment 
Quest Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CopperFixx™

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. 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

Principal Display Panel - 57g Jar Carton
COPPERFIXX 
capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68229-500-021 in 1 CARTON01/01/201602/25/2022
1NDC:68229-500-0157 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/201602/25/2022
Labeler - Quest Products, Inc. (075402441)
Establishment
NameAddressID/FEIBusiness Operations
Fill Tech USA965596435manufacture(68229-500)

Revised: 2/2022
Document Id: d8db8360-303f-9b90-e053-2995a90a5dee
Set id: 5a90ee65-5fcd-4491-9ffe-d4cebd8f2552
Version: 3
Effective Time: 20220225
 
Quest Products, Inc.