Copperfixx ointment

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.

Otc - keep out of reach of children section

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.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding, ask a health professional before use.

Directions

Spl unclassified section

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

Spl unclassified section

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.

Ingredients and appearance - Product information

Copperfixx ointment- Capsaicin

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Capsaicin ( UNII: S07O44R1ZM)( Capsaicin - UNII: S07O44R1ZM ) 0.25 gin 100 mL

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part348 USA

Labeler - Quest Products, Inc.( 075402441)

Establishment

Name ID/FEI Business Operations
Quest Products, Inc. 075402441 MANUFACTURE( 68229-500)

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