Label: ODEUR PREMIUM BODY CLEANSER- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69798-002-01, 69798-002-02 - Packager: SJ Bio Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 14, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
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INACTIVE INGREDIENT
Polyquatermium-10, Methyl Hydroxyethylcellulose, Allantoin, Black Strap Powder, Oleic Acid, Lauryl Glucoside, Polysorbate 85, 1,2-Hexanediol, Caprylic/Capric Triglyceride, Oryza Sativa (Rice) Bran Extract, Centella Asiatica Extract, Curcuma Longa (Turmeric) Root Extract, Phaseolus Radiatus Seed Extract, Artemisia Vulgaris Extract, Arctium Lappa Root Extract, Hippophae Rhamnoides Extract, Crataegus Oxyacantha Extract, Rheum Palmatum Root Extract, Bambusa Vulgaris Extract, Hamamelis Virginiana (Witch Hazel) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Panax Ginseng Root Extract, Propolis Extract, Sapindus Mukorossi Fruit Extract, Disodium EDTA, Diglycerin, Hyaluronic Acid, Hydrolyzed Collagen, Acetyl Hexapeptide-8, Copper Tripeptide, Butylene Glycol, Lauramidopropyl Betaine, Shea Butteramidopropyl Betaine, Capryl/Capramidopropyl Betaine, Sodium Cocoamphoacetate, Trehalose, Lavandula Angustifolia (lavender) Flower Extract, Pelargonium Graveolens Extract, Eucalyptus Globulus Leaf Extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ODEUR PREMIUM BODY CLEANSER
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69798-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 0.33 mg in 660 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE) SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) TREHALOSE (UNII: B8WCK70T7I) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) ALLANTOIN (UNII: 344S277G0Z) OLEIC ACID (UNII: 2UMI9U37CP) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYSORBATE 85 (UNII: A7F3N56197) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) RICE BRAN (UNII: R60QEP13IC) CENTELLA ASIATICA (UNII: 7M867G6T1U) TURMERIC (UNII: 856YO1Z64F) MUNG BEAN (UNII: 1LIB31N73G) ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) CRATAEGUS LAEVIGATA FLOWER (UNII: 85EAT04F4H) RHEUM PALMATUM ROOT (UNII: G025DAL7CE) BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02) ASIAN GINSENG (UNII: CUQ3A77YXI) PROPOLIS WAX (UNII: 6Y8XYV2NOF) SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y) EDETATE DISODIUM (UNII: 7FLD91C86K) DIGLYCERIN (UNII: 3YC120743U) HYALURONIC ACID (UNII: S270N0TRQY) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) PREZATIDE COPPER (UNII: 6BJQ43T1I9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69798-002-02 1 in 1 CARTON 08/30/2018 1 NDC:69798-002-01 660 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/30/2018 Labeler - SJ Bio Co., Ltd. (689514379) Registrant - SJ Bio Co., Ltd. (689514379) Establishment Name Address ID/FEI Business Operations SJ Bio Korea Co., Ltd. 695828501 manufacture(69798-002)
