TOMMIE COPPER PAIN RELIEF- trolamine salicylate 10% cream

Tommie Copper Pain Relief by

Drug Labeling and Warnings

Tommie Copper Pain Relief by is a Otc medication manufactured, distributed, or labeled by Tommie Copper, Inc., Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Trolamine Salicylate 10%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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

WARNINGS

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, do not bandage tightly or use with a heating pad, avoid 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding ask a health professional.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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, Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Mentha Piperita (Peppermint) Oil, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOMMIE COPPER PAIN RELIEF 
trolamine salicylate 10% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72562-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
MINERAL OIL (UNII: T5L8T28FGP)
CHAMOMILE (UNII: FGL3685T2X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CUCUMBER (UNII: YY7C30VXJT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
WATER (UNII: 059QF0KO0R)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
CETYL ALCOHOL (UNII: 936JST6JCN)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
JUNIPER BERRY (UNII: O84B5194RL)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLPARABEN (UNII: A2I8C7HI9T)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72562-223-25	70 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/19/2021

Labeler - Tommie Copper, Inc. (081176569)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(72562-223)