Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 6fadc288-68e7-9f32-e053-2991aa0a339b

Route

TOPICAL

Published

Effective Date 2016-02-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Arbutin (2 g) Adenosine (0.04 g)

Inactive Ingredients

Water Butylene Glycol

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2018-06-01

Description

Arbutin, Adenosine

Medication Information

Warnings and Precautions

Precautions

1. If the cosmetic causes red rash, swollenness or itching by exposure to sunlight during the use, you are advised to stop using it immediately and you may consult a pharmacist or a doctor

2. It is not advised to use the cosmetic on the skin where you have scars

3. Precautions for storage

ⓐ Keep it out of infants or children’s reach

ⓑ Keep it out of the place where exposure to direct sunlight exists

Indications and Usage

How To Use: Take moderate amount and spread it over desired area for natural skin tone evenly.

It can be used as regenerative cream for irritated skin or after peeling. You can apply it before sleeping due to excellent regenerative effect.

Dosage and Administration

for external use only

Description

Arbutin, Adenosine

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Butylene Glycol, etc.

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Arbutin, Adenosine

Structured Label Content

Indications and Usage (34067-9)

How To Use: Take moderate amount and spread it over desired area for natural skin tone evenly.

It can be used as regenerative cream for irritated skin or after peeling. You can apply it before sleeping due to excellent regenerative effect.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

Precautions

1. If the cosmetic causes red rash, swollenness or itching by exposure to sunlight during the use, you are advised to stop using it immediately and you may consult a pharmacist or a doctor

2. It is not advised to use the cosmetic on the skin where you have scars

3. Precautions for storage

ⓐ Keep it out of infants or children’s reach

ⓑ Keep it out of the place where exposure to direct sunlight exists

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water, Butylene Glycol, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Arbutin, Adenosine

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARBUTIN", "unii": "C5INA23HXF", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ADENOSINE", "unii": "K72T3FS567", "classCode": "ACTIB", "strengthNumerator": "0.04", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "How To Use: Take moderate amount and spread it over desired area for natural skin tone evenly. It can be used as regenerative cream for irritated skin or after peeling. You can apply it before sleeping due to excellent regenerative effect.", "34068-7": "for external use only", "34071-1": "Precautions 1. If the cosmetic causes red rash, swollenness or itching by exposure to sunlight during the use, you are advised to stop using it immediately and you may consult a pharmacist or a doctor 2. It is not advised to use the cosmetic on the skin where you have scars 3. Precautions for storage ⓐ Keep it out of infants or children’s reach ⓑ Keep it out of the place where exposure to direct sunlight exists", "50565-1": "keep out of reach of the children", "51727-6": "Water, Butylene Glycol, etc.", "55105-1": "Skin Protectant", "55106-9": "Arbutin, Adenosine"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:00.303560 · Updated: 2026-03-14T22:55:49.080281