NDC 70488-0011 J9 Ultra Advanced Intensive Scalp Pack V2

Dimethicone

NDC Product Code 70488-0011

NDC 70488-0011-1

Package Description: 20 mL in 1 TUBE

NDC Product Information

J9 Ultra Advanced Intensive Scalp Pack V2 with NDC 70488-0011 is a a human over the counter drug product labeled by Musee Cosmetic Co.,ltd.. The generic name of J9 Ultra Advanced Intensive Scalp Pack V2 is dimethicone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Musee Cosmetic Co.,ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


J9 Ultra Advanced Intensive Scalp Pack V2 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIMETHICONE 1 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • BENTONITE (UNII: A3N5ZCN45C)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Musee Cosmetic Co.,ltd.
Labeler Code: 70488
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-13-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

J9 Ultra Advanced Intensive Scalp Pack V2 Product Label Images

J9 Ultra Advanced Intensive Scalp Pack V2 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Dimethicone

Inactive Ingredient

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Apply to the scalp and gently rub it to absorb it

Warnings

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 sunlight2. do not use in the injured area3. precautions during storage and handling a) keep out of reach of children b) keep out of direct sunlight4. if contact with eyes, wash it immediately

Dosage & Administration

For topical use only

* Please review the disclaimer below.

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