Label: COPPERLIFE FOOT- dimethicone 1% cream
- NDC Code(s): 72562-211-01
- 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, Boswellia Serrata (Frankincense) Extract, Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Extract, Zingiber Officinale (Ginger) Root Extract, Capsicum Annuum (Paprika) Extract, Curcuma Longa (Tumeric) Root Extract, Trifolium Pratense (Clover) Flower Extract, Salix Alba (Willow) Bark Extract, Avena Sativa (Oat) Kernel 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, Anthemis Nobilis (Roman Chamomile) Flower Oil, Melaleuca Altrnifolia (Tea Tree) Leaf Oil, Ceramide NP.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COPPERLIFE FOOT
dimethicone 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72562-211 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) PAPRIKA (UNII: X72Z47861V) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GINGER (UNII: C5529G5JPQ) 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) TURMERIC (UNII: 856YO1Z64F) TEA TREE OIL (UNII: VIF565UC2G) CETYL ALCOHOL (UNII: 936JST6JCN) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FRANKINCENSE (UNII: R9XLF1R1WM) CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D) 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) TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) WILLOW BARK (UNII: S883J9JDYX) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72562-211-01 28 g in 1 TUBE; Type 0: Not a Combination Product 09/08/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/08/2021 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(72562-211)
