SPL v1
SPL
SPL Set ID 0fc1d1bb-2bb6-48b7-aaab-247761a01cca
Route
TOPICAL
Published
Effective Date 2020-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (1.0 g) Adenosine (0.02 g)
Inactive Ingredients
Water Dipropylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-12-01

Description

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Purpose

Purpose: Skin Brightening, Anti wrinkle


Medication Information

Purpose

Purpose: Skin Brightening, Anti wrinkle

Description

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Uses

Uses:

For skin brightening and anti-wrinkle

Warnings

Warnings:

1. Discontinue use if the following symptoms occur. If symptoms are extreme consult a dermatologist. 1) Symptoms such as red dots, swollenness, itching, stimulation during use. 2) Symptoms such as the ones mentioned in 1) occur on the applied area. 2. Do not apply to parts of the skin that have rashes, are cut, or are infected. 3. Directions for storage and handling. 1) The lid must be closed after use. 2) Keep out of reach of babies and children. 3) Store in a cool and dry place and avoid exposure to direct sunlight.

Directions

Directions: Apply two times at morning and night onto the skin daily

Active Ingredient

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Inactive Ingredient

Inactive ingredients: 

Water, Dipropylene Glycol, Glycerin, Trehalose, Panthenol, Butylene Glycol, Tranexamic Acid, 1,2-Hexanediol, Centella Asiatica Extract, Paeonia Suffruticosa Root Extract, Polyglyceryl-10 Laurate, Chamomilla Recutita (Matricaria) Flower Extract, Betaine, Arginine, Carbomer, Glyceryl Caprylate, Xanthan Gum, Ethylhexylglycerin, Sodium Hyaluronate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Pantolactone, Diethylhexyl Sodium Sulfosuccinate, Hamamelis Virginiana (Witch Hazel) Extract, Viola Tricolor Extract, Lavandula Angustifolia (Lavender) Flower Extract, Centaurea Cyanus Flower Extract, Hydrolyzed Hyaluronic Acid, Sea Water, Portulaca Oleracea Extract, Rhodiola Rosea Extract, Asparagus Officinalis Extract, Acanthopanax Sessiliflorus Bark Extract, Camellia Sinensis Leaf Extract, Cinnamomum Camphora (Camphor) Leaf Extract, Citrus Unshiu Peel Extract, Brassica Campestris (Rapeseed) Extract, Camellia Japonica Leaf Extract, Agastache Rugosa Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Morus Alba Leaf Extract, Disodium EDTA

Keep Out of Reach of Children

Keep out of reach of babies and children.

Package Label.principal Display Panel


Structured Label Content

Uses

Uses:

For skin brightening and anti-wrinkle

Purpose (PURPOSE)

Purpose: Skin Brightening, Anti wrinkle

Warnings (WARNINGS)

Warnings:

1. Discontinue use if the following symptoms occur. If symptoms are extreme consult a dermatologist. 1) Symptoms such as red dots, swollenness, itching, stimulation during use. 2) Symptoms such as the ones mentioned in 1) occur on the applied area. 2. Do not apply to parts of the skin that have rashes, are cut, or are infected. 3. Directions for storage and handling. 1) The lid must be closed after use. 2) Keep out of reach of babies and children. 3) Store in a cool and dry place and avoid exposure to direct sunlight.

Directions

Directions: Apply two times at morning and night onto the skin daily

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: 

Water, Dipropylene Glycol, Glycerin, Trehalose, Panthenol, Butylene Glycol, Tranexamic Acid, 1,2-Hexanediol, Centella Asiatica Extract, Paeonia Suffruticosa Root Extract, Polyglyceryl-10 Laurate, Chamomilla Recutita (Matricaria) Flower Extract, Betaine, Arginine, Carbomer, Glyceryl Caprylate, Xanthan Gum, Ethylhexylglycerin, Sodium Hyaluronate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Pantolactone, Diethylhexyl Sodium Sulfosuccinate, Hamamelis Virginiana (Witch Hazel) Extract, Viola Tricolor Extract, Lavandula Angustifolia (Lavender) Flower Extract, Centaurea Cyanus Flower Extract, Hydrolyzed Hyaluronic Acid, Sea Water, Portulaca Oleracea Extract, Rhodiola Rosea Extract, Asparagus Officinalis Extract, Acanthopanax Sessiliflorus Bark Extract, Camellia Sinensis Leaf Extract, Cinnamomum Camphora (Camphor) Leaf Extract, Citrus Unshiu Peel Extract, Brassica Campestris (Rapeseed) Extract, Camellia Japonica Leaf Extract, Agastache Rugosa Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Morus Alba Leaf Extract, Disodium EDTA

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of babies and children.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)