SPL v1
SPL
SPL Set ID 4506817e-7a31-4cbc-8b46-d1b1188171cf
Route
TOPICAL
Published
Effective Date 2019-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (0.5 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-03-01

Description

Active ingredients: Niacinamide 2.0%

Purpose

Purpose: Skin Brightening


Medication Information

Purpose

Purpose: Skin Brightening

Description

Active ingredients: Niacinamide 2.0%

Uses

Uses

■ Helps brighten and rehydrate dull, lackluster skin

■ Helps improve skin’s moisture-retention level.

■ Helps make your skin refreshed and glowing.

■ Helps to illuminate your complexion

Warnings

Warnings:

For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with the dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Do not reuse the sheet once used. Keep out of reach of children.

Directions

Directions

■ Start with a dry, cleansed face.

■ Remove from sachet and gently unfold and carefully place mask over the entire face, smoothing to fit the curves of the face and around eyes, nose, and mouth.

■ Leave on for 10 to 20 minutes, as desired.

■ Gently remove mask and lightly massage any remaining liquid into your skin, or wipe off. Do not rinse.

■ Discard the mask after a single use.

Active Ingredient

Active ingredients: Niacinamide 2.0%

Inactive Ingredient

Inactive ingredients:

Water, Glycerin, Dipropylene Glycol, Methylpropanediol, Hydroxyethylcellulose, 1,2-Hexanediol, Propanediol, PEG-60 Hydrogenated Castor Oil, Trehalose, Honey Extract, Carbomer, Arginine, Allantoin, Citrus Grandis (Grapefruit) Seed Extract, Dipotassium Glycyrrhizate, Glycyrrhiza Glabra (Licorice) Root Extract, Schizandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Zingiber Officinale (Ginger) Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Acorus Calamus Root Extract, Fragrance, Sodium Hyaluronate, Panthenol, Propolis Extract, Royal Jelly Extract, Caprylyl Glycol, Glyceryl , Acrylate/Acrylic Acid Copolymer, Propylene Glycol, PVM/MA Copolymer, Glutathione, Perilla Ocymoides Leaf Extract, Diamond powder

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

Uses

■ Helps brighten and rehydrate dull, lackluster skin

■ Helps improve skin’s moisture-retention level.

■ Helps make your skin refreshed and glowing.

■ Helps to illuminate your complexion

Purpose (PURPOSE)

Purpose: Skin Brightening

Warnings (WARNINGS)

Warnings:

For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with the dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Do not reuse the sheet once used. Keep out of reach of children.

Directions

Directions

■ Start with a dry, cleansed face.

■ Remove from sachet and gently unfold and carefully place mask over the entire face, smoothing to fit the curves of the face and around eyes, nose, and mouth.

■ Leave on for 10 to 20 minutes, as desired.

■ Gently remove mask and lightly massage any remaining liquid into your skin, or wipe off. Do not rinse.

■ Discard the mask after a single use.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Glycerin, Dipropylene Glycol, Methylpropanediol, Hydroxyethylcellulose, 1,2-Hexanediol, Propanediol, PEG-60 Hydrogenated Castor Oil, Trehalose, Honey Extract, Carbomer, Arginine, Allantoin, Citrus Grandis (Grapefruit) Seed Extract, Dipotassium Glycyrrhizate, Glycyrrhiza Glabra (Licorice) Root Extract, Schizandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Zingiber Officinale (Ginger) Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Acorus Calamus Root Extract, Fragrance, Sodium Hyaluronate, Panthenol, Propolis Extract, Royal Jelly Extract, Caprylyl Glycol, Glyceryl , Acrylate/Acrylic Acid Copolymer, Propylene Glycol, PVM/MA Copolymer, Glutathione, Perilla Ocymoides Leaf Extract, Diamond powder

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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