SPL v1
SPL
SPL Set ID 1f30971a-39cc-98ca-e063-6394a90a2004
Route
TOPICAL
Published
Effective Date 2024-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1 g)
Inactive Ingredients
Polyethylene Terephthalate (intrinsic Viscosity 0.40-0.70) Polyurethane-39 Cyclomethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-09

Description

DIMETHICONE 5%

Purpose

SCAR REMOVAL

Dosage and Administration

For external use only.


Medication Information

Purpose

SCAR REMOVAL

Dosage and Administration

For external use only.

Description

DIMETHICONE 5%

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 day

Until you can apply 24 hours a day each scar sheet

can be used repeatedly and when ánother new scar

patch becomes difficult to clean or paste replace

another new scar sheet.

Section 51945-4

Warning

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 usedimmediately.

Must not be used for not completely healed or

infected- wounds and damaged or acne skin.

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

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 usedimmediately.

Must not be used for not completely healed or

infected- wounds and damaged or acne skin.

If it's affixed to unclean skin or too tightly, rt may

cause rashes. At this time, it should be

reduced to stick and stick for less time.

Do Not Use

Discontinue use if any irritation or adverse reaction occurs

Active Ingredient

DIMETHICONE 5%

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 usedimmediately.

Must not be used for not completely healed or

infected- wounds and damaged or acne skin.

If it's affixed to unclean skin or too tightly, rt may

cause rashes. At this time,it should be

reduced to stick and stick for less time.

Inactive Ingredients

POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.40-0.70) ,POLYURETHANE-39 ,CYCLOMETHICONE

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 (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 day

Until you can apply 24 hours a day each scar sheet

can be used repeatedly and when ánother new scar

patch becomes difficult to clean or paste replace

another new scar sheet.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SCAR REMOVAL

Warning

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 usedimmediately.

Must not be used for not completely healed or

infected- wounds and damaged or acne skin.

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)

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 usedimmediately.

Must not be used for not completely healed or

infected- wounds and damaged or acne skin.

If it's affixed to unclean skin or too tightly, rt may

cause rashes. At this time, it should be

reduced to stick and stick for less time.

Do Not Use (Do not use)

Discontinue use if any irritation or adverse reaction occurs

Active Ingredient (ACTIVE INGREDIENT)

DIMETHICONE 5%

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 usedimmediately.

Must not be used for not completely healed or

infected- wounds and damaged or acne skin.

If it's affixed to unclean skin or too tightly, rt may

cause rashes. At this time,it should be

reduced to stick and stick for less time.

Inactive Ingredients (Inactive ingredients)

POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.40-0.70) ,POLYURETHANE-39 ,CYCLOMETHICONE

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

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