SPL v1
SPL
SPL Set ID 05ece831-63e8-d347-e063-6294a90a4347
Route
TOPICAL
Published
Effective Date 2023-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (5 g) Adenosine (0.04 g) Arbutin
Inactive Ingredients
Water Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-09-01

Description

Arbutin, Niacinamide, Adenosine


Medication Information

Warnings and Precautions

[Precautions for use]

1. During using product or after use, if there are any abnormal symptoms or side effects such as red spots, swelling, or itching on the area of use due to direct sunlight, con sult with a specialist. 2. Refrain from using on areas with scars, etc. 3. Pre cautions for storage and handling A) Keep out of reach of children B) Store away from direct sunlight 4. For arbutin, papules and mild itching have been repo rted in 「Human Application Test Data」.

Indications and Usage

Before use, remove sweat, water, and oil, and apply evenly to the armpit while rolling the ball in a clean state, then dry completely before wearing clothes.

Dosage and Administration

topical use only

Description

Arbutin, Niacinamide, Adenosine

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Alcohol Denat

Dipropylene Glycol

1,2-Hexanediol

PEG-60 Hydrogenated Castor Oil

Methyl Diisopropyl Propionamide

Silica

Caprylyl Glycol

Carbomer

Tromethamine

Allantoin

Ethylhexylglycerin

Disodium EDTA

Rosmarinus Officinalis (Rosemary) Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Centella Asiatica Extract

Salvia Officinalis (Sage) Leaf Extract

Portulaca Oleracea Extract

Nelumbo Nucifera Flower Extract

Olea Europaea (Olive) Fruit Extract

Melaleuca Alternifolia (Tea Tree) Extract

Tremella Fuciformis (Mushroom) Extract

Salix Alba (Willow) Bark Extract

Glycerin

Butylene Glycol

Sodium Hyaluronate

Glutathione

Fragrance

Benzyl Salicylate

Coumarin

Limonene

Linalool

Section 51945-4

Section 55105-1

skin protect

Section 55106-9

Arbutin, Niacinamide, Adenosine


Structured Label Content

Indications and Usage (34067-9)

Before use, remove sweat, water, and oil, and apply evenly to the armpit while rolling the ball in a clean state, then dry completely before wearing clothes.

Dosage and Administration (34068-7)

topical use only

Warnings and Precautions (34071-1)

[Precautions for use]

1. During using product or after use, if there are any abnormal symptoms or side effects such as red spots, swelling, or itching on the area of use due to direct sunlight, con sult with a specialist. 2. Refrain from using on areas with scars, etc. 3. Pre cautions for storage and handling A) Keep out of reach of children B) Store away from direct sunlight 4. For arbutin, papules and mild itching have been repo rted in 「Human Application Test Data」.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Alcohol Denat

Dipropylene Glycol

1,2-Hexanediol

PEG-60 Hydrogenated Castor Oil

Methyl Diisopropyl Propionamide

Silica

Caprylyl Glycol

Carbomer

Tromethamine

Allantoin

Ethylhexylglycerin

Disodium EDTA

Rosmarinus Officinalis (Rosemary) Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Centella Asiatica Extract

Salvia Officinalis (Sage) Leaf Extract

Portulaca Oleracea Extract

Nelumbo Nucifera Flower Extract

Olea Europaea (Olive) Fruit Extract

Melaleuca Alternifolia (Tea Tree) Extract

Tremella Fuciformis (Mushroom) Extract

Salix Alba (Willow) Bark Extract

Glycerin

Butylene Glycol

Sodium Hyaluronate

Glutathione

Fragrance

Benzyl Salicylate

Coumarin

Limonene

Linalool

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protect

Section 55106-9 (55106-9)

Arbutin, Niacinamide, Adenosine


Advanced Ingredient Data


Raw Label Data

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