Pain Relief Cream, Trolamine Salicylate 10%

Manufacturer
Tommie Copper, Inc.
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:44

Label at a glance#

ProductTommie Copper Pain Relief Maximum Strength
Active ingredientTROLAMINE SALICYLATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Trolamine Salicylate 10%

OTC - PURPOSE SECTION

Topical Analgesic.

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

For external use only.

Allergy Alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product use only as directed, avoid taking a bath or shower within 1 hour before or after applying, do not bandage or use with a heating pad, avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Adults and children 12 years of age: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313518trolamine salicylate 10 % Topical CreamPSN3
313518trolamine salicylate 100 MG/ML Topical CreamSCD3
313518trolamine salicylate 10 % Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72562-103-03Tommie Copper Pain ReliefMaximum Strength85 g in 1 TUBECREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72562-103TOMMIE COPPER PAIN RELIEF MAXIMUM STRENGTH (TROLAMINE SALICYLATE 10%) CREAM [TOMMIE COPPER, INC.]3Current NDC, Legacy NDC, 1 package rows20241217_b622c14f-9bf3-0bbd-e053-2a95a90a2adc.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72562-10372562-103-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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 Relief Maximum StrengthTROLAMINE SALICYLATE 10%Tommie Copper, Inc.b622c14f-9bf3-0bbd-e053-2a95a90a2adc2024-12-15WarningsExact identifier
ndc (package): 72562-103-03
ndc (product): 72562-103
ndc11 (package): 72562010303
spl id: 29591d5a-d9ba-4148-e063-6394a90af237
spl set id: b622c14f-9bf3-0bbd-e053-2a95a90a2adc

Reported adverse events (FAERS/openFDA)#

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