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
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 August 11, 2021

If you are a consumer or patient please visit this version.

  • 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

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    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)