Label: TOMMIE COPPER PAIN RELIEF ROLLER- camphor 3.5%, menthol 3.5% liquid
- NDC Code(s): 72562-125-03, 72562-125-25
- Packager: Tommie Copper, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 9, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
TOMMIE COPPER PAIN RELIEF ROLLER
camphor 3.5%, menthol 3.5% liquidProduct 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)
