ODEUR PREMIUM BODY CLEANSER- menthol gel 
SJ Bio Co., Ltd.

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.

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69798-002_Odeur Premium Body Cleanser

Menthol 0.05%

Skin Protectant

Body Cleansing

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


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

Keep away from infants and children.

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

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

image description

ODEUR PREMIUM BODY CLEANSER 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69798-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.33 mg  in 660 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69798-002-021 in 1 CARTON08/30/2018
1NDC:69798-002-01660 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/30/2018
Labeler - SJ Bio Co., Ltd. (689514379)
Registrant - SJ Bio Co., Ltd. (689514379)
Establishment
NameAddressID/FEIBusiness Operations
SJ Bio Korea Co., Ltd.695828501manufacture(69798-002)

Revised: 2/2022
Document Id: d802c438-7fef-d051-e053-2995a90a8e6f
Set id: 4581586b-14f3-48f2-a624-3e69a3089e81
Version: 5
Effective Time: 20220214
 
SJ Bio Co., Ltd.