ODEUR SENIOR PREMIUM CLEANSER- menthol gel

ODEUR Senior Premium Cleanser by

Drug Labeling and Warnings

ODEUR Senior Premium Cleanser by is a Otc medication manufactured, distributed, or labeled by SJ Bio Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol (0.1%)

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Body Cleansing

DOSAGE & ADMINISTRATION

Push out adequate amount of Senior Clean Bio and apply it on shower towel or hands. Make fluent bubble, scrub and massage from hair to body, and wash out with warm water.

WARNINGS

Immediately wash off when it is in mouth or eyes.
Keep in cool place and keep away from the sun.

KEEP OUT OF REACH OF CHILDREN

Keep away from infants and children.

ASK DOCTOR

Consult with doctor when there is any symptom such as erythema, swelling, irritation or sensitization.

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

INGREDIENTS AND APPEARANCE

ODEUR SENIOR PREMIUM CLEANSER 
menthol gel

Product 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)