FDA Label for Biocorneum Advanced Scar Treatment Anti-itch
View Indications, Usage & Precautions
Biocorneum Advanced Scar Treatment Anti-itch Product Label
The following document was submitted to the FDA by the labeler of this product Sientra, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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. If
swallowed, get medical help or contact a
poison 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
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
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