TOMMIE COPPER PAIN RELIEF ROLLER- camphor 3.5%, menthol 3.5% liquid

Tommie Copper Pain Relief Roller by

Drug Labeling and Warnings

Tommie Copper Pain Relief Roller 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

Camphor 3.5%, Menthol 3.5%

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. Flammable--Do not use while smoking or near heat or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. 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 to the affected area not more than 3 to 4 times daily.

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Extract, Aminomethyl Propanol, Anthemis Nobilis (Roman Chamomile) Flower Oil, Arnica Montana (Arnica) Flower Extract, Boswellia Serrata (Frankincense) Extract, Cannabis Sativa (Hemp) Extract, Capsicum Annuum (Paprika) Extract, Citrus Limon (Lemon) Peel Oil, Curcuma Longa (Tumeric) Root Extract, Ethyhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, FD&C Blue No 1, Glycerin, Isopropyl Alcohol, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Trifolium Pratense (Clover) Flower Extract, Water, Zingiber Officinale (Ginger) Root Extract.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOMMIE COPPER PAIN RELIEF ROLLER 
camphor 3.5%, menthol 3.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72562-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
GINGER (UNII: C5529G5JPQ)
SALIX ALBA BARK (UNII: 205MXS71H7)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CANNABIS SATIVA SEED (UNII: QE567Z26NG)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PAPRIKA (UNII: X72Z47861V)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
LEMON OIL (UNII: I9GRO824LL)
TURMERIC (UNII: 856YO1Z64F)
TEA TREE OIL (UNII: VIF565UC2G)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72562-125-03	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2020
2	NDC: 72562-125-25	70 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/18/2020

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(72562-125)