Label: ODEUR SENIOR PREMIUM CLEANSER- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69798-001-01, 69798-001-02 - 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 May 11, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
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INACTIVE INGREDIENT
Cocamide DEA, Lauramidopropyl Betaine, Oleic Acid, Water, PEG-60 Castor Oil, Propylene Glycol, Glycerin, Butylene Glycol, Sodium Cocoamphoacetate, Oryza Sativa (Rice) Bran Extract, Camellia Sinensis Leaf Extract, Shea Butteramidopropyl Betaine, Polysorbate 80, Black Strap Powder, 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, Eucalyptus Globulus Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Lecithin, Capryl/Capramidopropyl Betaine, Polyquaternium-10, Panax Ginseng Root Extract, Hydroxyethylcellulose, Allantoin, 6-Aminocaproic Acid, Hexanediol, Caprylic/Capric Triglyceride, Disodium EDTA, Tocopheryl Acetate, Citric Acid, Propolis Extract, Fragrance
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ODEUR SENIOR PREMIUM CLEANSER
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69798-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.63 g in 632.19 g Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) OLEIC ACID (UNII: 2UMI9U37CP) WATER (UNII: 059QF0KO0R) PEG-60 CASTOR OIL (UNII: VXP26NM2XX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) RICE BRAN (UNII: R60QEP13IC) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POLYSORBATE 80 (UNII: 6OZP39ZG8H) 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) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE) POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS) ASIAN GINSENG (UNII: CUQ3A77YXI) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) ALLANTOIN (UNII: 344S277G0Z) AMINOCAPROIC ACID (UNII: U6F3787206) HEXANEDIOL (UNII: ZIA319275I) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPOLIS WAX (UNII: 6Y8XYV2NOF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69798-001-02 1 in 1 CARTON 05/11/2015 1 NDC:69798-001-01 632.19 g 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 05/11/2015 Labeler - SJ Bio Co., Ltd. (689514379) Registrant - SJ Bio Co., Ltd. (689514379) Establishment Name Address ID/FEI Business Operations SJ Bio Co., Ltd. 689514379 manufacture(69798-001)
