FDA.reportPublic FDA data

CopperFixx

Manufacturer
Quest Products, Inc. | Fill Tech USA
Effective date
2015-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:29:31

Label at a glance#

ProductCopperFixx
Active ingredientCapsaicin
Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin .025%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - STOP USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 57g Jar Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68229-500-022022-02-25C16284748780-19d75b9d0-262f-f424-e053-dadaa90a57ceCopperFixx™
68229-500-022020-01-31C16284748780-19d75b9d0-262f-f424-e053-dadaa90a57ceCopperFixx™

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68229-50068229-500-01, 68229-500-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CapsaicinS07O44R1ZMACTIB
Aloe Vera LeafZY81Z83H0XIACT
Water059QF0KO0RIACT
Copper789U1901C5IACT
Isopropyl Myristate0RE8K4LNJSIACT
Cetostearyl Alcohol2DMT128M1SIACT
Behentrimonium Methosulfate5SHP745C61IACT
Polysorbate 60CAL22UVI4MIACT
Cetyl Alcohol936JST6JCNIACT
Coconut OilQ9L0O73W7LIACT
Avocado Oil6VNO72PFC1IACT
Jojoba Oil724GKU717MIACT
Stearic Acid4ELV7Z65APIACT
Dimethicone92RU3N3Y1OIACT
Butylene Glycol3XUS85K0RAIACT
Sodium LactateTU7HW0W0QTIACT
Silk, Acid Hydrolyzed (1000 MW)8549W658QVIACT
Amino Acids, SilkV0L00EX1IAIACT
TocopherolR0ZB2556P8IACT
Allantoin344S277G0ZIACT
Lavender OilZBP1YXW0H8IACT
Edetate Disodium7FLD91C86KIACT
Diazolidinyl UreaH5RIZ3MPW4IACT
Sodium BenzoateOJ245FE5EUIACT
Potassium Sorbate1VPU26JZZ4IACT
Lemon OilI9GRO824LLIACT
Tea Tree OilVIF565UC2GIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d8db8360-303f-9b90-e053-2995a90a5dee5a90ee65-5fcd-4491-9ffe-d4cebd8f25522022-02-25WarningsExact identifier
spl set id: 5a90ee65-5fcd-4491-9ffe-d4cebd8f2552

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.