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, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Echinacea Angustifolia (Coneflower) Extract, Ethyhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, FD&C Blue No 1, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Isopropyl Alcohol, Juniperus Communis (Juniper) Fruit Extract, Phenoxyethanol, Water

LabelLabel

TOMMIE COPPER PAIN RELIEF ROLLER 
camphor 3.5%, menthol 3.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72562-105
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 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
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)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
CALENDULA ARVENSIS LEAF (UNII: 3U3U118F2L)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
JUNIPER BERRY (UNII: O84B5194RL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72562-105-0385 g in 1 BOTTLE; Type 0: Not a Combination Product11/30/2020
2NDC:72562-105-0128 g in 1 BOTTLE; Type 0: Not a Combination Product11/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/30/2020
Labeler - Tommie Copper, Inc. (081176569)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72562-105)

Revised: 1/2023
Document Id: f201ec4f-8ba4-0997-e053-2a95a90aa19b
Set id: b4cd4fed-e8c8-db85-e053-2995a90a708b
Version: 2
Effective Time: 20230111
 
Tommie Copper, Inc.