Label: BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH- hydrocortisone acetate 1% gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 71241-002-05, 71241-002-99 - Packager: Sientra, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
-
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
- Other Information
- Inactive Ingredients
- Questions?
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
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
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH
hydrocortisone acetate 1% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71241-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 1 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71241-002-99 1 in 1 CARTON 05/08/2018 1 NDC:71241-002-05 5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/08/2018 Labeler - Sientra, Inc. (010209877)
