Description:
PROSIL SPF15
SILICONE STICK FOR SCARS
GLIDE-ON THERAPY FOR YOUR SCARS
Scaraid Us Spf Stick
FDA Label NDC 84440-626
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 Scaraid Us Spf (NDC 84440-626). 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 description:, active ingredients:, dosage & administration:, purpose:, indications & usage:, directions:, warnings:, warnings and precautions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients:
Avobenzone - 3% Sunscreen
Octocrylene - 5% Sunscreen agent
Octinoxate - 4% Sunscreen agent
Dosage & Administration:
Apply 15 minutes before sun exposure. Clean and dry scar site before each application. Apply ScarAid® liberally over the entire
scar. May be covered with a bandage. Repeat several times daily for 8–12 weeks or until scar stops responding. To remove, wipe off with a clean cloth or tissue.
Purpose:
SILICONE STICK FOR SCARS
BROAD SPECTRUM UVA/UVB SUNSCREEN
HELPS PREVENT SUNBURN
Indications & Usage:
SILICONE STICK FOR SCARS
BROAD SPECTRUM UVA/UVB SUNSCREEN
HELPS PREVENT SUNBURN
Directions:
Apply 15 minutes before sun exposure. Clean and dry scar site
before each application. Apply ScarAid® liberally over the entire scar. May be
covered with a bandage. Repeat several times daily for 8–12 weeks or until
scar stops responding. To remove, wipe off with a clean cloth or tissue. Store
between 55°F–95°F (13°C–35°C).
Warnings:
FOR EXTERNAL USE ONLY
Warnings And Precautions:
EXTERNAL USE ONLY
CAUTIONS: Stop use and ask a doctor if rash occurs. Do not use on
damaged or broken skin. For children under 5 year of age, use under
adult supervision. Children under 6 months of age: Ask a doctor.
Cautions:
Stop use and ask a doctor if rash occurs. Do not use on damaged
or broken skin. For children under 5 year of age, use under adult supervision.
Children under 6 months of age: Ask a doctor.
Keep Out Of Reach Of Children:
KEEP OUT OF REACH OF CHILDREN:
Ask A Doctor:
Ask a doctor about using SCARAID SPF with children under 6 months old.
Storage:
Store between 55°F–95°F (13°C–35°C).
Contact Information:
MADE IN THE USA U.S. Patent No. 8,557,287
BIODERMIS LLC
www.biodermis.com
1820 Whitney Mesa Drive, Suite 100
Henderson, Nevada 89014 USA
800.322.3729 (USA)
702.260.4466 (INTL)
Inactive Ingredients:
Silicone
Primary Package Label
4.25g Tube:
17g Tube:
1g Sample Tube:
* Please review the disclaimer below.
