NDC 71241-002 Biocorneum Advanced Scar Treatment Anti-itch

Hydrocortisone Acetate 1%

NDC Product Code 71241-002

NDC CODE: 71241-002

Proprietary Name: Biocorneum Advanced Scar Treatment Anti-itch 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: Hydrocortisone Acetate 1% 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

  • 71241 - Sientra, Inc.
    • 71241-002 - Biocorneum Advanced Scar Treatment Anti-itch

NDC 71241-002-99

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 5 g in 1 BOTTLE, PUMP (71241-002-05)

NDC Product Information

Biocorneum Advanced Scar Treatment Anti-itch with NDC 71241-002 is a a human over the counter drug product labeled by Sientra, Inc.. The generic name of Biocorneum Advanced Scar Treatment Anti-itch is hydrocortisone acetate 1%. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1235742 and 1235747.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Biocorneum Advanced Scar Treatment Anti-itch 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.

  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)

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: Sientra, Inc.
Labeler Code: 71241
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-08-2018 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.

Biocorneum Advanced Scar Treatment Anti-itch Product Label Images

Biocorneum Advanced Scar Treatment Anti-itch 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 Ingredient

Active IngredientPurpose Hydrocortisone acetate 1%..............Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, soaps, detergents and cosmetics. Other uses of this product should be only under the advice and supervision of a physician.Biocorneum can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes,(such as joints).

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily for up to 7 days. Children under 2 years of age: Do not use, consult a physician.

Other Information

Protect product in this container from excessive heat and direct sun.

Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethyl Isosorbide, Pentylene Glycol, Propylene Glycol, Silicon Dioxide

Questions?

Call 888.708.0808

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Ifswallowed, get medical help or contact apoison control center immediately.

Warnings

For external use only.Avoid contact with eyes.Do not use for treatment of diaper rash.Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.Keep out of the reach of children.If swallowed, get medical help or contact a poison control center immediately.

Dosage & Administration

DirectionsAdults and children 2 years of age and older:• Ensure that the aected area is clean and dry.• Apply a thin, even layer up to 3-4 timesdaily for up to 7 days, or as directed byyour physician.• Allow to dry.

* Please review the disclaimer below.