ODEUR PREMIUM BODY CLEANSER- menthol gel

Odeur Premium Body Cleanser by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 0.05%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Body Cleansing

DOSAGE & ADMINISTRATION

Push out adequate amount of ODEUR cleanser and apply it on a shower towel or hands. Make fluent bubble, scrub and massage to body. 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

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

INGREDIENTS AND APPEARANCE

ODEUR PREMIUM BODY CLEANSER 
menthol gel

Product 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
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)
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)

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 Co., Ltd.		689514379	manufacture(69798-002)