SPL v1
SPL
SPL Set ID 80861d31-100a-4c97-b9c7-afc3d8b3371a
Route
TOPICAL
Published
Effective Date 2016-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (1.10 g)
Inactive Ingredients
Water Dipropylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-05-01

Description

Active Ingredient: Niacinamide 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Niacinamide 2.0%

Warnings

Precautions on use: 1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms. A) If there are red spots, swelling, itchiness, or irritation B) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight. 2. Precautions on storage and handling A) Make sure to close the cap after use. B) Keep out of the reach of children. C) Do not keep the product in a hot or cold place or a place getting direct sunlight. 3. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

Suggested Use

Suggested use: Nourish the skin with anti-wrinkle eye cream and apply an appropriate amount of the essence to the whole face and neck gently and evenly.

Active Ingredient

Active Ingredient: Niacinamide 2.0%

Inactive Ingredient

Inactive Ingredients: Water, Dipropylene Glycol, Phytosqualane, Glycerin, Phenyl Trimethicone, Panthenol, Cyclopentasiloxane/PEG-10 Dimethicone/Vinyl Dimechicone Cross Polymer, Cyclopentasiloxane, Hydrogenated Lecithin, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Polyacrylamide/C13-14 Isoparaffin/ Laureth-7, CeramideNP/Hydrogenated Polydecene/Stearic Acid/ButyrospermumParkii(Shea) Butter/Ceteareth-20//Glyceryl Citrate/Lactate/Linoleate/Oleate Butylene glycol, Ethoxydiglycol, Trimethylpentanediol/Adipic Acid Copolymer, Sodium Polyacrylate, Phenoxyethanol, Beta-Glucan, Tocopheryl Acetate, Carbomer, Triethanolamine, Fragrance, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Xanthan Gum, Disodium EDTA, Copper Tripeptide-1, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4

Dosage & Administration

Dosage & administration: Apply 3~4g of essence to face evenly.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Precautions on use: 1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms. A) If there are red spots, swelling, itchiness, or irritation B) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight. 2. Precautions on storage and handling A) Make sure to close the cap after use. B) Keep out of the reach of children. C) Do not keep the product in a hot or cold place or a place getting direct sunlight. 3. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

Suggested Use (Suggested use)

Suggested use: Nourish the skin with anti-wrinkle eye cream and apply an appropriate amount of the essence to the whole face and neck gently and evenly.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Dipropylene Glycol, Phytosqualane, Glycerin, Phenyl Trimethicone, Panthenol, Cyclopentasiloxane/PEG-10 Dimethicone/Vinyl Dimechicone Cross Polymer, Cyclopentasiloxane, Hydrogenated Lecithin, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Polyacrylamide/C13-14 Isoparaffin/ Laureth-7, CeramideNP/Hydrogenated Polydecene/Stearic Acid/ButyrospermumParkii(Shea) Butter/Ceteareth-20//Glyceryl Citrate/Lactate/Linoleate/Oleate Butylene glycol, Ethoxydiglycol, Trimethylpentanediol/Adipic Acid Copolymer, Sodium Polyacrylate, Phenoxyethanol, Beta-Glucan, Tocopheryl Acetate, Carbomer, Triethanolamine, Fragrance, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Xanthan Gum, Disodium EDTA, Copper Tripeptide-1, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage & administration: Apply 3~4g of essence to face evenly.

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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