BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH- hydrocortisone acetate 1% gel 
Sientra, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Keep out of reach of children. If

swallowed, get medical help or contact a

poison control center immediately.

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.

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.

bioc-label1Biocorneum HC

BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH 
hydrocortisone acetate 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71241-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 1 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71241-002-991 in 1 CARTON05/08/2018
1NDC:71241-002-055 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/08/2018
Labeler - Sientra, Inc. (010209877)

Revised: 1/2021
Document Id: b8ab3acc-d508-1454-e053-2995a90ad733
Set id: 6bb6aa59-65cc-2852-e053-2991aa0a087c
Version: 2
Effective Time: 20210111
 
Sientra, Inc.