SPL v1
SPL
SPL Set ID b49fd4ed-2bd3-4611-9096-720151f2c752
Route
TOPICAL
Published
Effective Date 2016-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (0.6 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-03-02

Description

Active Ingredient: NIACINAMIDE 2.0%

Purpose

Purpose: Skin protectant and brightening


Medication Information

Purpose

Purpose: Skin protectant and brightening

Description

Active Ingredient: NIACINAMIDE 2.0%

Warnings

Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

Active Ingredient

Active Ingredient: NIACINAMIDE 2.0%

Inactive Ingredient

Inactive Ingredients: WATER, GLYCERIN, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, PROPANEDIOL, 1,2-HEXANEDIOL, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, PEG-60 HYDROGENATED CASTOR OIL, CARBOMER, TREHALOSE, TRIETHANOLAMINE, XANTHAN GUM, FRAGRANCE, DISODIUM EDTA, ALLANTOIN, SODIUM HYALURONATE, BETA-GLUCAN, LILIUM CANDIDUM FLOWER EXTRACT, LEONTOPODIUM ALPINUM FLOWER/LEAF EXTRACT, CONVALLARIA MAJALIS ROOT EXTRACT, MAGNOLIA LILIFLORA FLOWER EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT

Indications & Usage

Indications & Usage: 1. Use skin toner on cleansed face and take out the mask. 2. Place and attach mask on the face centered around the eyes. 3. Take off the mask after 10~20 minutes and pat the remaining essence until completely absorbed.

Dosage & Administration

Dosage & Administration: Use twice or three times a week.

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 and brightening

Warnings (WARNINGS)

Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: NIACINAMIDE 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: WATER, GLYCERIN, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, PROPANEDIOL, 1,2-HEXANEDIOL, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, PEG-60 HYDROGENATED CASTOR OIL, CARBOMER, TREHALOSE, TRIETHANOLAMINE, XANTHAN GUM, FRAGRANCE, DISODIUM EDTA, ALLANTOIN, SODIUM HYALURONATE, BETA-GLUCAN, LILIUM CANDIDUM FLOWER EXTRACT, LEONTOPODIUM ALPINUM FLOWER/LEAF EXTRACT, CONVALLARIA MAJALIS ROOT EXTRACT, MAGNOLIA LILIFLORA FLOWER EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT

Indications & Usage (INDICATIONS & USAGE)

Indications & Usage: 1. Use skin toner on cleansed face and take out the mask. 2. Place and attach mask on the face centered around the eyes. 3. Take off the mask after 10~20 minutes and pat the remaining essence until completely absorbed.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage & Administration: Use twice or three times a week.

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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