BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH

Manufacturer
Sientra, Inc.
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:57:10

Label at a glance#

ProductBIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH
Active ingredientHYDROCORTISONE ACETATE
Label structure10 sections

Indications and 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

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose

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

Uses

OTC - WHEN USING SECTION

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

INFORMATION FOR PATIENTS SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 888.708.0808

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If

swallowed, get medical help or contact a

poison control center immediately.

WARNINGS SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bioc-label1bioc-label1Biocorneum HCBiocorneum HC

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71241-002-992024-01-30C16284748780-11030e365-3c81-111a-e063-dadaa90a10e2Drug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71241-00271241-002-05, 71241-002-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b8ab3acc-d508-1454-e053-2995a90ad7336bb6aa59-65cc-2852-e053-2991aa0a087c2021-01-11WarningsExact identifier
spl id: b8ab3acc-d508-1454-e053-2995a90ad733
spl set id: 6bb6aa59-65cc-2852-e053-2991aa0a087c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.