TOMMIE COPPER FOOT- dimethicone 1% cream

Tommie Copper Foot by

Drug Labeling and Warnings

Tommie Copper Foot by is a Otc medication manufactured, distributed, or labeled by Tommie Copper, Inc., Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TOMMIE COPPER FOOT 
dimethicone 1% cream

Product 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)