TOMMIE COPPER PAIN RELIEF ROLLER- camphor 3.5%, menthol 3.5% liquid 
Tommie Copper, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pain Relief Liquid Roller

Camphor 3.5%, Menthol 3.5%


Topical Analgesic

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

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.

If pregnant or breast-feeding ask a health professional.

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

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily.

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.

Label

Label

TOMMIE COPPER PAIN RELIEF ROLLER 
camphor 3.5%, menthol 3.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72562-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72562-125-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product12/18/2020
2NDC:72562-125-2570 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/18/2020
Labeler - Tommie Copper, Inc. (081176569)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72562-125)

Revised: 1/2023
Document Id: f1db8ba7-30ee-151c-e053-2995a90a4ea4
Set id: b6c3d6eb-b485-33b8-e053-2a95a90a41e1
Version: 3
Effective Time: 20230109
 
Tommie Copper, Inc.