Biocorneum Advanced Scar Treatment Anti-itch
Hydrocortisone Acetate 1%
Sientra, Inc.
Human Otc Drug
NDC 71241-002Biocorneum Advanced Scar Treatment Anti-itch also known as Hydrocortisone Acetate 1% is a human otc drug labeled by 'Sientra, Inc.'. National Drug Code (NDC) number for Biocorneum Advanced Scar Treatment Anti-itch is 71241-002. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Biocorneum Advanced Scar Treatment Anti-itch drug includes Hydrocortisone Acetate - 1 g/100g . The currest status of Biocorneum Advanced Scar Treatment Anti-itch drug is Active.
Drug Information:
| Drug NDC: | 71241-002 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Biocorneum Advanced Scar Treatment Anti-itch |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydrocortisone Acetate 1% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sientra, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROCORTISONE ACETATE - 1 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 08 May, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Sientra, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1235742
1235747
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 3X7931PO74
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71241-002-99 | 1 BOTTLE, PUMP in 1 CARTON (71241-002-99) / 5 g in 1 BOTTLE, PUMP (71241-002-05) | 08 May, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Product Elements:
Biocorneum advanced scar treatment anti-itch hydrocortisone acetate 1% hydrocortisone acetate hydrocortisone dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane)
Indications and Usage:
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.
When Using:
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).
Dosage and Administration:
Directions adults 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 times daily for up to 7 days, or as directed by your physician. ⢠allow to dry.
Information for Patients:
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.
Package Label Principal Display Panel:
Bioc-label1 biocorneum hc
Further Questions:
Questions? call 888.708.0808