PAIN RELIEF LIQUID 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, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit 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, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Water.

Label

PAIN RELIEF LIQUID ROLLER 
camphor 3.5%, menthol 3.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72562-167
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
JUNIPER BERRY (UNII: O84B5194RL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CUCUMBER (UNII: YY7C30VXJT)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72562-167-2570 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/19/2021
Labeler - Tommie Copper, Inc. (081176569)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72562-167)

Revised: 1/2023
Document Id: f1db89cb-4a58-1461-e053-2995a90a6d0e
Set id: c9f0447e-de43-16a5-e053-2995a90a05c1
Version: 2
Effective Time: 20230109
 
Tommie Copper, Inc.