ScarAid SPF DailyMed Label

Key Label Information#

Active Ingredients And Purpose

ACTIVE INGREDIENTS:

Avobenzone - 3% Sunscreen Octocrylene - 5% Sunscreen agent Octinoxate - 4% Sunscreen agent

PURPOSE:

SILICONE STICK FOR SCARS BROAD SPECTRUM UVA/UVB SUNSCREEN HELPS PREVENT SUNBURN

Uses

INDICATIONS & USAGE:

SILICONE STICK FOR SCARS BROAD SPECTRUM UVA/UVB SUNSCREEN HELPS PREVENT SUNBURN

Warnings

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.

ASK A DOCTOR:

Ask a doctor about using SCARAID SPF with children under 6 months old.

Directions And Dosage

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.

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).

Other Label Information

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) EC REP: MDSS GmbH, SCHIFFGRABEN 41 30175 HANNOVER, GERMANY

INACTIVE INGREDIENTS:

Silicone

Primary Package Label

4.25g Tube: 17g Tube: 1g Sample Tube:

Label Images#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84440-619-01	ScarAid SPF	1 g in 1 TUBE	STICK	1	1
84440-619-17	ScarAid SPF	17 g in 1 TUBE	STICK	17	1
84440-619-42	ScarAid SPF	4.25 g in 1 TUBE	STICK	4.25	1

Products#

ScarAid SPF
Silicone stick with SPF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84440-619	84440-619-01, 84440-619-42, 84440-619-17

Ingredients#

Name, UNII, Kind table
Name	UNII	Kind
SILICON	Z4152N8IUI	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB

Complete SPL Sections#

DESCRIPTION:

DESCRIPTION SECTION

PROSIL SPF15 SILICONE STICK FOR SCARS GLYDE-ON THERAPY FOR YOUR SCARS

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 3% Sunscreen Octocrylene - 5% Sunscreen agent Octinoxate - 4% Sunscreen agent

DOSAGE & ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

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:

OTC - PURPOSE SECTION

SILICONE STICK FOR SCARS BROAD SPECTRUM UVA/UVB SUNSCREEN HELPS PREVENT SUNBURN

INDICATIONS & USAGE:

INDICATIONS & USAGE SECTION

SILICONE STICK FOR SCARS BROAD SPECTRUM UVA/UVB SUNSCREEN HELPS PREVENT SUNBURN

DIRECTIONS:

INSTRUCTIONS FOR USE SECTION

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:

WARNINGS SECTION

FOR EXTERNAL USE ONLY

WARNINGS AND PRECAUTIONS:

WARNINGS AND PRECAUTIONS SECTION

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:

OTC - ASK DOCTOR/PHARMACIST SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN:

ASK A DOCTOR:

OTC - ASK DOCTOR SECTION

Ask a doctor about using SCARAID SPF with children under 6 months old.

STORAGE:

STORAGE AND HANDLING SECTION

Store between 55°F–95°F (13°C–35°C).

CONTACT INFORMATION:

OTC - QUESTIONS SECTION

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) EC REP: MDSS GmbH, SCHIFFGRABEN 41 30175 HANNOVER, GERMANY

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Silicone

Primary Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4.25g Tube: 17g Tube: 1g Sample Tube:

Source Document#

Source XML