Label: TOMMIE COPPER FOOT- dimethicone 1% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 23, 2021

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

  • ACTIVE INGREDIENT

    Dimethicone 1%

  • PURPOSE


    Skin Protectant

  • INDICATIONS & USAGE

    Helps prevent and temporarily protects chafed, chapped, or cracked skin.

  • WARNINGS

    For external use only. When using this product do not get into eyes. 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. Do not use on deep puncture wounds, animal bites, and serious burns.

  • 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

    Apply as needed.

  • INACTIVE INGREDIENT

    Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Panthenol, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia (Coneflower) Extract, Ilex Paraguariensis (Yerba Mater) Leaf Extract, Avena Sativa (Oat) Kernel Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sorbitol, Lecithin, Xanthan Gum, Oleic Acid, Iron Oxides (CI 77491), Phenoxyethanol, Ethylhexylglycerin, Steareth-20, Sodium Chloride, Colloidal Oatmeal, 4-t-Butylcyclohexanol, Pentylene Glycol, Benzalkonium Chloride, Mentha Piperita (Peppermint) Oil, Ceramide NP.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    TOMMIE COPPER FOOT 
    dimethicone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72562-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    OATMEAL (UNII: 8PI54V663Y)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CERAMIDE NP (UNII: 4370DF050B)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CUCUMBER (UNII: YY7C30VXJT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    WATER (UNII: 059QF0KO0R)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    OAT (UNII: Z6J799EAJK)  
    SORBITOL (UNII: 506T60A25R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72562-222-0128 g in 1 TUBE; Type 0: Not a Combination Product08/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/19/2021
    Labeler - Tommie Copper, Inc. (081176569)
    Registrant - Derma Care Research Labs, LLC (116817470)