FDA.reportPublic FDA data

Pain Relief Liquid Spray

Manufacturer
Tommie Copper, Inc. | Derma Care Research Labs, LLC
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:43

Label at a glance#

ProductTommie Copper Pain Relief
Active ingredientMENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

OTC - PURPOSE SECTION


Topical Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

WARNINGS SECTION

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a health professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Alcohol Denat., Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Propylene Glycol, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1430458menthol 16 % Topical SprayPSN3
1430458menthol 160 MG/ML Topical SpraySCD3
1430458menthol 16 % Topical SpraySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72562-910-04Tommie Copper Pain Relief113 g in 1 CANSPRAY1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72562-910TOMMIE COPPER PAIN RELIEF (MENTHOL 16%) SPRAY [TOMMIE COPPER, INC.]3Current NDC, Legacy NDC, 1 package rows20241217_b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72562-91072562-910-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA ARVENSIS LEAF3U3U118F2LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
JUNIPER BERRYO84B5194RLIACT
GREEN TEA LEAFW2ZU1RY8B0IACT

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
Tommie Copper Pain ReliefMENTHOL 16%Tommie Copper, Inc.b4dfa5fa-2d61-db1e-e053-2a95a90a7ac82024-12-15WarningsExact identifier
ndc (package): 72562-910-04
ndc (product): 72562-910
ndc11 (package): 72562091004
spl id: 29591527-d0db-0eaa-e063-6394a90a082e
spl set id: b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8

Reported adverse events (FAERS/openFDA)#

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