SPL v1
SPL
SPL Set ID 672e1623-d564-12f4-e053-2991aa0afda7
Route
TOPICAL
Published
Effective Date 2018-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (99.97 g)
Inactive Ingredients
Gold

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-03-12

Description

dimethicone


Medication Information

Warnings and Precautions

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

- Keep out of reach of infants and children

- Do not to store in a place with high/low temperature and exposed to direct sunlight

Indications and Usage

[for use with mask sheet]

1. after washing, remove moisture entirely to arrange skin texture

2. apply the wine gold serum (step 1) onto the face equaly and rub the serum softly like massae to absorb perfectly

3. unfolding the mask (step 2), position the mask on the fact according to position of eyes and mouth

4. remove the mask sheet after 15~30 minutes, after that softly pat any remaining essence into skin like massage

[for scalp care]

apply proper amount to the scalp

Dosage and Administration

for external use only

Description

dimethicone

Section 50565-1

Keep out of reach of children.

Section 51727-6

gold

Section 51945-4

Section 55105-1

scalp care

Section 55106-9

dimethicone


Structured Label Content

Indications and Usage (34067-9)

[for use with mask sheet]

1. after washing, remove moisture entirely to arrange skin texture

2. apply the wine gold serum (step 1) onto the face equaly and rub the serum softly like massae to absorb perfectly

3. unfolding the mask (step 2), position the mask on the fact according to position of eyes and mouth

4. remove the mask sheet after 15~30 minutes, after that softly pat any remaining essence into skin like massage

[for scalp care]

apply proper amount to the scalp

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

- Keep out of reach of infants and children

- Do not to store in a place with high/low temperature and exposed to direct sunlight

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

gold

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

scalp care

Section 55106-9 (55106-9)

dimethicone


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)