FDA.reportPublic FDA data

CopperGel

Manufacturer
CopperRelief, LLC
Effective date
2018-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:22

Label at a glance#

ProductCopperGel
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Camphor 3.5%

Menthol 3.5%

OTC - PURPOSE SECTION

Purpose:

Topical Analgesic

INDICATIONS & USAGE SECTION

USES: for the temporary relief of minor aches and pains in muscles and joints associated with:

  • strains
  • sprains
  • sports injuries
  • arthritis
  • bruises

WARNINGS SECTION

WARNINGS:

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • with other topical pain relievers
  • with heating pads or heating devices

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness or irritation develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:

  • clean the affected area before applying product
  • adults and children 2 years of age and older: apply to affected not more than 3 to 4 times daily

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1, Copper PCA, Ethylhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine, Water (Aqua)

SPL UNCLASSIFIED SECTION

Distributed By: Copper Relief, LLC

Wayzata, MN 55391

www.coppergel.com

MADE IN THE USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CopperGel

KNOCK OUT THE PAIN™
Topical Analgesic Gel

NET WT. 3 OZ (85g)

coppergel labelcoppergel label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1998765camphor 3.5 % / menthol 3.5 % Topical GelPSN1
1998765camphor 0.035 MG/MG / menthol 0.035 MG/MG Topical GelSCD1
1998765camphor 3.5 % / menthol 3.5 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72081-001-032020-01-31C16284748780-19d75b9cf-e5a3-f424-e053-dadaa90a57ceCopperGel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72081-001-03CopperGel1 in 1 CARTONGEL11
72081-001-03CopperGel85 g in 1 TUBE, WITH APPLICATORGEL851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72081-001COPPERGEL (CAMPHOR, MENTHOL) GEL [COPPERRELIEF, LLC]1Legacy NDC, 2 package rows20180205_6469c4e0-af7b-2ab1-e053-2991aa0a85f3.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72081-00172081-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
ISOPROPYL ALCOHOLND2M416302IACT
COPPER PIDOLATE497G7G1SL1IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
6469c4e0-af7c-2ab1-e053-2991aa0a85f36469c4e0-af7b-2ab1-e053-2991aa0a85f32018-02-04WarningsExact identifier
spl id: 6469c4e0-af7c-2ab1-e053-2991aa0a85f3
spl set id: 6469c4e0-af7b-2ab1-e053-2991aa0a85f3

Reported adverse events (FAERS/openFDA)#

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