NDC 72650-101 Incellderm Vallatto Oilmist

Niacinamide, Adenosine

NDC Product Code 72650-101

NDC 72650-101-01

Package Description: 50 mL in 1 CONTAINER

NDC Product Information

Incellderm Vallatto Oilmist with NDC 72650-101 is a a human over the counter drug product labeled by Riman Korea Co., Ltd.. The generic name of Incellderm Vallatto Oilmist is niacinamide, adenosine. The product's dosage form is oil and is administered via topical form.

Labeler Name: Riman Korea Co., Ltd.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Incellderm Vallatto Oilmist 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.

  • NIACINAMIDE 2 g/100mL
  • ADENOSINE .04 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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: Riman Korea Co., Ltd.
Labeler Code: 72650
Marketing Category: UNAPPROVED DRUG OTHER - 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: 03-30-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Incellderm Vallatto Oilmist Product Label Images

Incellderm Vallatto Oilmist 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

Active Ingredients

Niacinamide, Adenosine

Inactive Ingredients

HippophaeRhamnoides Water, Caprylic/Capric Triglyceride, Butylene Glycol,1,2-Hexanediol, Glycerin, Hydroxyacetophenone, Propanediol, Water, Artemisia Capillaris Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Betaine, Camellia Japonica Seed Oil, Rosa Canina Fruit Oil, Cereus Grandiflorus (Cactus) Extract, Hydrogenated Lecithin, Lavandula Angustifolia (Lavender) Oil, Sodium Chloride, Olea Europaea (Olive) Fruit Extract, Phytosteryl/OctyldodecylLauroyl Glutamate, Centella Asiatica Extract, Ceramide NP, Polygonum Cuspidatum Root Extract, ScutellariaBaicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Fucus Vesiculosus Extract, Prunella Vulgaris Extract, Thymus Vulgaris (Thyme) Flower/Leaf/Stem Extract, Lavandula Angustifolia (Lavender) Flower Extract, Origanum Vulgare Extract, Sodium Hyaluronate, Limonene, Linalool, Citral

Purpose

Helps to brighten the skin.Helps to improve wrinkles in the skin.

Warnings

1. Consult a physician if red spots, swollenness, itchiness, or any other abnormal symptoms or side effects develops on the applied area during or after use or under direct sunlight.2. Do not use on wound, etc.3. Precautions for handling and storage a) Keep out of the reach of children b) Avoid direct sunlight

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Use at any time, lightly shaking up/down and spraying evenly, after adjusting the distance based on skin type. Wait until naturally absorbed

Directions

For external use only

* Please review the disclaimer below.