Label: TOMMIE COPPER FOOT- dimethicone 1% cream
- NDC Code(s): 72562-222-01
- Packager: Tommie Copper, Inc.
- 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 January 9, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
TOMMIE COPPER FOOT
dimethicone 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72562-222 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72562-222-01 28 g in 1 TUBE; Type 0: Not a Combination Product 08/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/19/2021 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(72562-222)
