SPL v1
SPL
SPL Set ID 50a0340e-2b13-6776-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arbutin (1 g) Adenosine (0.05 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-05-26

Description

Arbutin, Adenosine


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

1) Close the lid after use

2) Keep out of reach of infants and children

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

4. Use as avoiding eye areas.

Indications and Usage

Apply to the face and around the neck in the evening

Dosage and Administration

for external use only

Description

Arbutin, Adenosine

Section 50565-1

Keep out of reach of the children

Section 51727-6

Water, Glycerin, Etc

Section 51945-4

Section 55105-1

Skin Protectant - Whitening, Anti-Wrinkle

Section 55106-9

Arbutin, Adenosine


Structured Label Content

Indications and Usage (34067-9)

Apply to the face and around the neck in the evening

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

1) Close the lid after use

2) Keep out of reach of infants and children

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

4. Use as avoiding eye areas.

Section 50565-1 (50565-1)

Keep out of reach of the children

Section 51727-6 (51727-6)

Water, Glycerin, Etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant - Whitening, Anti-Wrinkle

Section 55106-9 (55106-9)

Arbutin, Adenosine


Advanced Ingredient Data


Raw Label Data

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