Biocorneum Gel
FDA Label NDC 84440-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biodermis Llc for the product Biocorneum (NDC 84440-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, skin cancer/skin aging alert, otc - keep out of reach of children, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Avobenzone 3%Sunscreen
Homosalate 15%Sunscreen
Meradimate 5%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 10%Sunscreen

Dosage Form: Gel

Uses

BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Directions

  • Ensure that the affected area is clean and dry.
  • Apply a thin, even layer twice daily.
  • Allow to dry. Wait 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor.

Other Information

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

Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Silicon Dioxide

Questions?

Call 800.322.3729

Principal Display Panel - 50 G Tube Carton

BIOCORNEUM®

ADVANCED
SCAR TREATMENT

SILISHIELD®
CROSSLINKED SILICONE
+ BROAD SPECTRUM SPF 30

NET WT 1.73 fl oz (50g)

Principal Display Panel (50 g Tube Carton)

Principal Display Panel (50 g Tube Carton)

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