SPL v1
SPL
SPL Set ID 37ef6a58-23b4-4ce5-b47d-eb176dc0c3d4
Route
TOPICAL
Published
Effective Date 2019-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (2.60 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. Replace the cap after use

5. Keep out of reach of children.

6. Avoid direct sunlight.

Directions

Directions:



Take proper amount and gently apply onto the face.

Active Ingredient

Active ingredients: Niacinamide 2.00%

Inactive Ingredient

Inactive ingredients:

Water, Butylene Glycol, PEG/PPG-17/6 Copolymer, Trehalose, Human Adipocyte Conditioned Media Extract, 1,2-Hexanediol, Caprylyl Glycol, Bis-PEG-18 Methyl Ether Dimethyl Silane, Ethylhexylglycerin, Salix Alba (Willow) Bark Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Glycerin, Cellulose Gum, Panthenol, PEG-60 Hydrogenated Castor Oil, Hamamelis Virginiana (Witch Hazel) Leaf Water, Disodium EDTA, Glyceryl Citrate/Lactate/Linoleate/Oleate, Sodium Hyaluronate, Olea Europaea (Olive) Fruit Oil, Polysorbate 60, Lilium Candidum, Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Convallaria Majalis Bulb/Root Extract, Magnolia Liliflora Flower Extract, Paeonia Lactiflora Extract, Palmitoyl Tripeptide-5, Fragrance

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. Replace the cap after use

5. Keep out of reach of children.

6. Avoid direct sunlight.

Directions

Directions:



Take proper amount and gently apply onto the face.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Niacinamide 2.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Butylene Glycol, PEG/PPG-17/6 Copolymer, Trehalose, Human Adipocyte Conditioned Media Extract, 1,2-Hexanediol, Caprylyl Glycol, Bis-PEG-18 Methyl Ether Dimethyl Silane, Ethylhexylglycerin, Salix Alba (Willow) Bark Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Glycerin, Cellulose Gum, Panthenol, PEG-60 Hydrogenated Castor Oil, Hamamelis Virginiana (Witch Hazel) Leaf Water, Disodium EDTA, Glyceryl Citrate/Lactate/Linoleate/Oleate, Sodium Hyaluronate, Olea Europaea (Olive) Fruit Oil, Polysorbate 60, Lilium Candidum, Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Convallaria Majalis Bulb/Root Extract, Magnolia Liliflora Flower Extract, Paeonia Lactiflora Extract, Palmitoyl Tripeptide-5, Fragrance

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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