J9 ULTRA ADVANCED INTENSIVE SCALP- dimethicone shampoo 
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, panthenol, etc.

scalp protectant

keep out of reach of the children


1) Moisten hair and scalp with warm water sufficiently.

2) Apply a proper amount to the hair and scalp and massage.

3) Rinse it after 5 minutes.

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

for external use only


image description

J9 ULTRA ADVANCED INTENSIVE SCALP 
dimethicone shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70488-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.666667 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70488-0005-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/22/2016
Labeler - MUSEE Cosmetic Co.,Ltd. (689605445)
Registrant - MUSEE Cosmetic Co.,Ltd. (689605445)
Establishment
NameAddressID/FEIBusiness Operations
MUSEE Cosmetic Co.,Ltd.689605445manufacture(70488-0005) , label(70488-0005) , pack(70488-0005)

Revised: 1/2017
Document Id: 4513dfa4-8a01-2fec-e054-00144ff8d46c
Set id: 2c6c4976-f477-62e4-e054-00144ff88e88
Version: 2
Effective Time: 20170101
 
MUSEE Cosmetic Co.,Ltd.