SPL v1
SPL
SPL Set ID 220119ae-e99a-ea7b-e063-6294a90a004d
Route
TOPICAL
Published
Effective Date 2024-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (1 g)
Inactive Ingredients
Polyurethane-39 Pegoterate Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Silicone gel 1%

Purpose

SCAR REMOVAL SHEETS

Dosage and Administration

For external use only.


Medication Information

Purpose

SCAR REMOVAL SHEETS

Dosage and Administration

For external use only.

Description

Silicone gel 1%

Uses

1.Clean and dry scar area.

2. Cut sheet according to the size and shape of the scar.

3. Peel off liner from adhesive side of sheet.

4. Apply adhesive side of sheet directly on scar.Apply 4 hours a day for the first two days, 8 hours a day for the next two days, and then increase by 2 hours a dayUntil you can apply 24 hours a day each scar sheet can be used repeatedly and when another new scar patch becomes difficult to clean or paste replace another new scar sheet.

Warnings

Use this product once scar or wound has been healing for at least 7 days. You may start using immediately on older scars. For old scars, the product can be used immediately.



Must not be used for not completely healed or infected- wounds and damagedoracneskin. If it's affixed to unclean

skin or too tightly, it may cause rashes. At this time. it should be reduced to stick and stick for less time.

Stop Use

on broken or irritated scalp

Active Ingredient

Silicone gel 1%

When Using Section

Use this product once scar or wound has been healing for at least 7 days. You may start using immediately on older scars. For old scars, the product can be used immediately.



Must not be used for not completely healed or infected-wounds and damagedoracneskin. If it's affixed to unclean skin or too tightly, it may cause rashes. At this time. it should be reduced to stick and stick for less time

Inactive Ingredients

polydimethylsiloxane, polyurethane film, pet.

Principal Display Panel

Keep Out of Reach of Children.

Keep Away From Children Under 3 Years Old And Pets,

Out Of Direct Sunlight And Store In A Cool, Dry Place


Structured Label Content

Uses

1.Clean and dry scar area.

2. Cut sheet according to the size and shape of the scar.

3. Peel off liner from adhesive side of sheet.

4. Apply adhesive side of sheet directly on scar.Apply 4 hours a day for the first two days, 8 hours a day for the next two days, and then increase by 2 hours a dayUntil you can apply 24 hours a day each scar sheet can be used repeatedly and when another new scar patch becomes difficult to clean or paste replace another new scar sheet.

Purpose

SCAR REMOVAL SHEETS

Warnings (WARNINGS)

Use this product once scar or wound has been healing for at least 7 days. You may start using immediately on older scars. For old scars, the product can be used immediately.



Must not be used for not completely healed or infected- wounds and damagedoracneskin. If it's affixed to unclean

skin or too tightly, it may cause rashes. At this time. it should be reduced to stick and stick for less time.

Stop Use (stop use)

on broken or irritated scalp

Active Ingredient (ACTIVE INGREDIENT)

Silicone gel 1%

When Using Section (When using section)

Use this product once scar or wound has been healing for at least 7 days. You may start using immediately on older scars. For old scars, the product can be used immediately.



Must not be used for not completely healed or infected-wounds and damagedoracneskin. If it's affixed to unclean skin or too tightly, it may cause rashes. At this time. it should be reduced to stick and stick for less time

Inactive Ingredients (Inactive ingredients)

polydimethylsiloxane, polyurethane film, pet.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dosage and Administration (Dosage and administration)

For external use only.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep Away From Children Under 3 Years Old And Pets,

Out Of Direct Sunlight And Store In A Cool, Dry Place


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)