FDA.reportPublic FDA data

J9 ULTRA ADVANCED INTENSIVE SCALP PACK V2

Manufacturer
MUSEE Cosmetic Co.,Ltd. | Kolmar Korea Co., Ltd.
Effective date
2019-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:11

Label at a glance#

ProductJ9 ULTRA ADVANCED INTENSIVE SCALP PACK V2
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

dimethicone

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

Apply to the scalp and gently rub it to absorb it

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

for topical use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200010dimethicone 1 % Topical CreamPSN1
200010dimethicone 10 MG/ML Topical CreamSCD1
200010dimethicone 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70488-0011-12020-09-27C16284748780-1ab0e2407-2ed0-f274-e053-dbdaa90a6471Drug Facts
70488-0011-12020-09-25C16284748780-1ab0e2407-2ed0-f274-e053-dbdaa90a6471Drug Facts
70488-0011-12020-07-22C16284748780-1ab0e2407-2ed0-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70488-0011-1J9 ULTRA ADVANCED INTENSIVE SCALP PACK V220 mL in 1 TUBECREAM201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70488-0011J9 ULTRA ADVANCED INTENSIVE SCALP PACK V2 (DIMETHICONE) CREAM [MUSEE COSMETIC CO.,LTD.]1Legacy NDC, 1 package rows20190413_8660cc31-f538-426d-e053-2a91aa0adb03.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70488-001170488-0011-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENTONITEA3N5ZCN45CIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8662fc27-2ee1-3875-e053-2991aa0ab2088660cc31-f538-426d-e053-2a91aa0adb032019-04-12WarningsExact identifier
spl id: 8662fc27-2ee1-3875-e053-2991aa0ab208
spl set id: 8660cc31-f538-426d-e053-2a91aa0adb03

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.