J9 ULTRA ADVANCED INTENSIVE SCALP PACK V2- dimethicone cream 
MUSEE Cosmetic Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

dimethicone

WATER
BENTONITE
CETEARYL ALCOHOL
BEHENYL ALCOHOL
PROPYLENE GLYCOL
STEARTRIMONIUM CHLORIDE
WATER
BEHENTRIMONIUM CHLORIDE
ISOPROPYL ALCOHOL
1,2-HEXANEDIOL
CYCLOPENTASILOXANE
FRAGRANCE
PEG-14M
PERSEA GRATISSIMA (AVOCADO) OIL
DISODIUM EDTA
SODIUM CITRATE
CITRIC ACID
PANTHENOL
WATER
BUTYLENE GLYCOL
CHITOSAN SUCCINAMIDE

enhance you health in scalp and akeep it if you want to be stylish

keep out of reach of the children

Apply to the scalp and gently rub it to absorb it

1. when using or after using comsetic products, consult a doctor if you notice any signs of red spots, swelling, or itching symptoms or side effects caused by direct sunlight

2. do not use in the injured area

3. precautions during storage and handling

a) keep out of reach of children

b) keep out of direct sunlight

4. if contact with eyes, wash it immediately

for topical use only

label

J9 ULTRA ADVANCED INTENSIVE SCALP PACK V2 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70488-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BENTONITE (UNII: A3N5ZCN45C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70488-0011-120 mL in 1 TUBE; Type 0: Not a Combination Product04/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/13/2019
Labeler - MUSEE Cosmetic Co.,Ltd. (689605445)
Registrant - MUSEE Cosmetic Co.,Ltd. (689605445)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(70488-0011)
Establishment
NameAddressID/FEIBusiness Operations
MUSEE Cosmetic Co.,Ltd.689605445label(70488-0011)

Revised: 4/2019
Document Id: 8662fc27-2ee1-3875-e053-2991aa0ab208
Set id: 8660cc31-f538-426d-e053-2a91aa0adb03
Version: 1
Effective Time: 20190412
 
MUSEE Cosmetic Co.,Ltd.