SPL v1
SPL
SPL Set ID a0cfe424-aeb1-48ba-9572-4e9885c842da
Route
TOPICAL
Published
Effective Date 2019-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (0.12 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-08-01

Description

Active ingredients: Niacinamide 2.00% 

Purpose

Purpose: Skin Brightening


Medication Information

Purpose

Purpose: Skin Brightening

Description

Active ingredients: Niacinamide 2.00% 

Uses

Uses:

Helps brighten skin tone.

Warnings

Warnings:

For external use only

1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product

2. Do not apply to open wounds.

3. Avoid contact with eyes.

Storage and handling

4. Keep in the refrigerator at 2-6°C.

5. Keep out of reach of children.

6. Avoid direct sunlight.

Directions

Directions:

Gently mix with AAPE powder to dissolve the mixture.

Take proper amount and gently apply onto the skin.

Active Ingredient

Active ingredients: Niacinamide 2.00% 

Inactive Ingredient

Inactive ingredients:

Water, Butylene Glycol, Glycerin, Sorbitol, Hydroxyacetophenone, Propanediol, Xanthan Gum, Allantoin, Adenosine, Caprylhydroxamic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Sophora Angustifolia Root Extract, Angelica Gigas Root Extract, Panax Ginseng Root Extract, Cnidium Officinale Root Extract, Glycine Max (Soybean) Seed Extract, Polygonum Multiflorum Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Acetyl Hexapeptide-8, Palmitoyl Tripeptide-5

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

Uses:

Helps brighten skin tone.

Purpose (PURPOSE)

Purpose: Skin Brightening

Warnings (WARNINGS)

Warnings:

For external use only

1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product

2. Do not apply to open wounds.

3. Avoid contact with eyes.

Storage and handling

4. Keep in the refrigerator at 2-6°C.

5. Keep out of reach of children.

6. Avoid direct sunlight.

Directions

Directions:

Gently mix with AAPE powder to dissolve the mixture.

Take proper amount and gently apply onto the skin.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Niacinamide 2.00% 

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Butylene Glycol, Glycerin, Sorbitol, Hydroxyacetophenone, Propanediol, Xanthan Gum, Allantoin, Adenosine, Caprylhydroxamic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Sophora Angustifolia Root Extract, Angelica Gigas Root Extract, Panax Ginseng Root Extract, Cnidium Officinale Root Extract, Glycine Max (Soybean) Seed Extract, Polygonum Multiflorum Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Acetyl Hexapeptide-8, Palmitoyl Tripeptide-5

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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