SPL v1
SPL
SPL Set ID e9ce1822-bf52-488d-8c5c-794eb5a13a02
Route
TOPICAL
Published
Effective Date 2016-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (1.0 g)
Inactive Ingredients
Green Tea Leaf Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-01-02

Description

Active Ingredient: Niacinamide 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Niacinamide 2.0%

Usage

Usage: Take an appropriate amount and gently apply it on the face

Warnings

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight 4. According to supporting evidence that prove its effect. It causes slight papular and uredo, when applying the same contained ingredient medicine.

Active Ingredient

Active Ingredient: Niacinamide 2.0%

Inactive Ingredient

Inactive Ingredients: Camellia Sinensis Leaf Extract, Glycerin, Ethylhexyl PalmitateEthylhexyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer /Cyclomethicone/Hydrogenated Lecithin/Alcohol/Aqua, Helianthus Annuus (Sunflower) Seed Oil, Allium Cepa (Onion) Bulb Extract, Beta-Glucan, Ceramide/Phospholipids/Phytosterols/Soybean Glycerides/ Stearyl Alcohol /Behenyl Alcohol, Cetearyl Alcohol, Cyclomethicone, 1,2-Hexanediol, Panthenol, Urtica Dioica (Nettle) Extract, Argania Spinosa Kernel Oil, Sodium Hyaluronate, Beeswax, Butyrospermum Parkii (Shea) Butter, Stearic Acid, Dimethicone, Ecklonia Cava Extract, Tocopheryl Acetate, Arginine, Carbomer, Palmitoyl Dipeptide-7, Xanthan Gum, Allantoin, Disodium EDTA, Citrus Paradisi (Grapefruit) Peel Oil

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Usage

Usage: Take an appropriate amount and gently apply it on the face

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight 4. According to supporting evidence that prove its effect. It causes slight papular and uredo, when applying the same contained ingredient medicine.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Camellia Sinensis Leaf Extract, Glycerin, Ethylhexyl PalmitateEthylhexyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer /Cyclomethicone/Hydrogenated Lecithin/Alcohol/Aqua, Helianthus Annuus (Sunflower) Seed Oil, Allium Cepa (Onion) Bulb Extract, Beta-Glucan, Ceramide/Phospholipids/Phytosterols/Soybean Glycerides/ Stearyl Alcohol /Behenyl Alcohol, Cetearyl Alcohol, Cyclomethicone, 1,2-Hexanediol, Panthenol, Urtica Dioica (Nettle) Extract, Argania Spinosa Kernel Oil, Sodium Hyaluronate, Beeswax, Butyrospermum Parkii (Shea) Butter, Stearic Acid, Dimethicone, Ecklonia Cava Extract, Tocopheryl Acetate, Arginine, Carbomer, Palmitoyl Dipeptide-7, Xanthan Gum, Allantoin, Disodium EDTA, Citrus Paradisi (Grapefruit) Peel Oil

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

KEEP OUT OF REACH OF CHILDREN

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


Advanced Ingredient Data


Raw Label Data

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