NDC 71447-030 Nelly Devuyst Bio Medical Bioacne Anti-redness Serum 30 Ml

Colloidal Oatmeal

NDC Product Code 71447-030

NDC CODE: 71447-030

Proprietary Name: Nelly Devuyst Bio Medical Bioacne Anti-redness Serum 30 Ml What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Colloidal Oatmeal What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 71447 - Laboratoires Druide Inc
    • 71447-030 - Nelly Devuyst Bio Medical Bioacne Anti-redness Serum 30 Ml

NDC 71447-030-01

Package Description: 1 TUBE in 1 BOX > 30 g in 1 TUBE (71447-030-00)

NDC Product Information

Nelly Devuyst Bio Medical Bioacne Anti-redness Serum 30 Ml with NDC 71447-030 is a a human over the counter drug product labeled by Laboratoires Druide Inc. The generic name of Nelly Devuyst Bio Medical Bioacne Anti-redness Serum 30 Ml is colloidal oatmeal. The product's dosage form is cream and is administered via topical form.

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.

Nelly Devuyst Bio Medical Bioacne Anti-redness Serum 30 Ml 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.


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.

  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • TURMERIC (UNII: 856YO1Z64F)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
  • HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • NELUMBO NUCIFERA ROOT OIL (UNII: 382005USDH)
  • JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
  • ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • STAR ANISE FRUIT (UNII: CK15HA8438)
  • SORBIC ACID (UNII: X045WJ989B)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • GINGER OIL (UNII: SAS9Z1SVUK)
  • GLYCOGEN (UNII: 309GSC92U1)
  • ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)

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: Laboratoires Druide Inc
Labeler Code: 71447
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: 10-14-2021 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.

Nelly Devuyst Bio Medical Bioacne Anti-redness Serum 30 Ml Product Label Images

Nelly Devuyst Bio Medical Bioacne Anti-redness Serum 30 Ml 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

Colloidal Oatmeal 1.3%

Purpose

Skin Protectant

Uses

▪ Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

Warnings

For external use only

Do Not Use

Consult a healthcare practitioner if symptoms worsen or last for more than 7 days.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

Rash occurs.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact Poison Control Center right away.

Directions

▪ Apply to affected area as needed.

Other Information

Protect the product in this container from excessive heat and direct sun. Store the product at room temperature 20 to 25°C (68 to 77°F).

Inactive Ingredients

Aloe Barbadensis Leaf Juice*, C10-18 Triglycerides, Oenothera Biennis (Evening Primrose) Oil*, Coco-Caprylate, Curcuma Longa Extract*, Propanediol, Polyglycery1-6 Distearate, Crataegus Oxyacantha Extract*, Crataegus oxyacantha (hawthorn), Glyceryl Stearate (2%), Nelumbo Nucifera Root Water, Jojoba Esters, Aspalathus Linearis Leaf Extract*, Sodium Stearoyl Glutamate, Polyglyceryl-3 Beeswax, Glycerin, Cetyl Alcohol, Tocopherol (Vitamin E), Salicylic Acid, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Illicium Verum (Anise) Fruit/Seed Oil* , Sorbic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Oil*, Glycogen.*Certified organic.

* Please review the disclaimer below.