SPL v1
SPL
SPL Set ID 1bdb079e-60fd-44c8-8a56-968348868b81
Route
TOPICAL
Published
Effective Date 2015-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (0.1 mg)
Inactive Ingredients
Water Methylpropanediol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-06-01

Description

Active Ingredient: Niacinamide 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Niacinamide 2.0%

Warnings

Warnings: 1. You must immediately discontinue using the product if any of the following symptoms occur, and since a prolonged usage will aggressive the symptoms, you must consult with a doctor specializing in dermatology. A. If abnormal symptoms such as red spots, swelling, itchiness and/or irritation occur. B. If the applied experience the above symptoms due to direct sunlight. 2. Do not use on areas with various wounds, eczema and/or dermatitis those who are sensitive to adhesive band-aids or poultice must take caution when using it. Keep away from your eyes and be sure to clean it immediately if it ever gets into an eye. 3. Safety cautions in storage and handling. A. Use immediately after you open the product. B. Do not store in high or low temperature locations and areas exposed to direct sunlight. C. Do not reuse a product that has already been used before. Keep out of reach of children. Keep away from the hands of infants and children.

Active Ingredient

Active Ingredient: Niacinamide 2.0%

Inactive Ingredient

Inactive Ingredients: WATER, METHYLPROPANEDIOL, GLYCERIN, BETAINE, DIGLYCERIN, POLYQUATERNIUM-51, PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT, ALOE BARBADENSIS LEAF JUICE, 1,2-HEXANEDIOL, ARCTIUM LAPPA ROOT EXTRACT, PHELLINUS LINTEUS EXTRACT, SOLUBLE COLLAGEN, HYDROGENATED LECITHIN, GLYCOSYL TREHALOSE, PHENOXYETHANOL, HYDROGENATED STARCH HYDROLYSATE, XANTHAN GUM, DIOSCOREA JAPONICA ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PUERARIA THUNBERGIANA ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, TROMETHAMINE, ETHYLHEXYLGLYCERIN, PORIA COCOS SCLEROTIUM EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, DIPROPYLENE GLYCOL, CELLULOSE GUM, ADENOSINE, DISODIUM EDTA, FRAGRANCE, SODIUM HYALURONATE, SODIUM PALMITOYL PROLINE, BUTYLENE GLYCOL, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, PEG/PPG-17/6 COPOLYMER, PEG-40 HYDROGENATED CASTOR OIL, CARBOMER, PVM/MA COPOLYMER, SODIUM POLYACRYLATE, RAFFINOSE, BIOSACCHARIDE GUM-1, LECITHIN, FOLIC ACID, CERAMIDE 3, CHOLESTEROL, CAPRYLYL GLYCOL, PANTHENOL, PALMITOYL TRIPEPTIDE-5, ACETYL HEXAPEPTIDE-8, PALMITOYL PENTAPEPTIDE-4

Indications & Usage

Indications & usage: A sufficient amount of the product is evenly applied and spread on the skin.

Dosage & Administration

Dosage & Administration: Take an appropriate amount of this product.

Keep Out of Reach of Children

Keep out of reach of children. Keep away from the hands of infants and children.

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings: 1. You must immediately discontinue using the product if any of the following symptoms occur, and since a prolonged usage will aggressive the symptoms, you must consult with a doctor specializing in dermatology. A. If abnormal symptoms such as red spots, swelling, itchiness and/or irritation occur. B. If the applied experience the above symptoms due to direct sunlight. 2. Do not use on areas with various wounds, eczema and/or dermatitis those who are sensitive to adhesive band-aids or poultice must take caution when using it. Keep away from your eyes and be sure to clean it immediately if it ever gets into an eye. 3. Safety cautions in storage and handling. A. Use immediately after you open the product. B. Do not store in high or low temperature locations and areas exposed to direct sunlight. C. Do not reuse a product that has already been used before. Keep out of reach of children. Keep away from the hands of infants and children.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: WATER, METHYLPROPANEDIOL, GLYCERIN, BETAINE, DIGLYCERIN, POLYQUATERNIUM-51, PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT, ALOE BARBADENSIS LEAF JUICE, 1,2-HEXANEDIOL, ARCTIUM LAPPA ROOT EXTRACT, PHELLINUS LINTEUS EXTRACT, SOLUBLE COLLAGEN, HYDROGENATED LECITHIN, GLYCOSYL TREHALOSE, PHENOXYETHANOL, HYDROGENATED STARCH HYDROLYSATE, XANTHAN GUM, DIOSCOREA JAPONICA ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PUERARIA THUNBERGIANA ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, TROMETHAMINE, ETHYLHEXYLGLYCERIN, PORIA COCOS SCLEROTIUM EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, DIPROPYLENE GLYCOL, CELLULOSE GUM, ADENOSINE, DISODIUM EDTA, FRAGRANCE, SODIUM HYALURONATE, SODIUM PALMITOYL PROLINE, BUTYLENE GLYCOL, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, PEG/PPG-17/6 COPOLYMER, PEG-40 HYDROGENATED CASTOR OIL, CARBOMER, PVM/MA COPOLYMER, SODIUM POLYACRYLATE, RAFFINOSE, BIOSACCHARIDE GUM-1, LECITHIN, FOLIC ACID, CERAMIDE 3, CHOLESTEROL, CAPRYLYL GLYCOL, PANTHENOL, PALMITOYL TRIPEPTIDE-5, ACETYL HEXAPEPTIDE-8, PALMITOYL PENTAPEPTIDE-4

Indications & Usage (INDICATIONS & USAGE)

Indications & usage: A sufficient amount of the product is evenly applied and spread on the skin.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage & Administration: Take an appropriate amount of this product.

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

Keep out of reach of children. Keep away from the hands of infants and children.

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


Advanced Ingredient Data


Raw Label Data

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