SPL v1
SPL
SPL Set ID f8b4d1b4-34df-ee9a-e053-6294a90aab5d
Route
TOPICAL
Published
Effective Date 2023-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (0.3 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-04-07

Description

Hydrogenated Polydecene,Niacinamide


Medication Information

Warnings and Precautions

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

Indications and Usage

take proper amount to the skin when needed

Dosage and Administration

for external use only

Description

Hydrogenated Polydecene,Niacinamide

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water,Glycerin,Dimethicone,Dipropylene Glycol,1,2-Hexanediol,Glyceryl Stearate,Stearyl Alcohol,Propanediol,Trehalose,Polyglyceryl-2 Stearate,Polysorbate 60,Caprylic/CapricTriglyceride,Cyclopentasiloxane,Olea Europaea (Olive) Fruit Oil,PEG-100 Stearate,Cetyl Alcohol,Sorbitan Olivate,Tromethamine,Fragrance,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Tocopheryl Acetate,Methyl Methacrylate Crosspolymer,Butylene Glycol,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Ethylhexylglycerin,Carbomer,Panthenol,Squalane,

Coptis Japonica Root Extract,Adenosine,Disodium EDTA,Sodium Hyaluronate,Borago Officinalis Extract,Centaurea Cyanus Flower Extract,Chamomilla Recutita (Matricaria) Flower Extract,Hyacinthus Orientalis (Hyacinth) Extract,Lavandula Angustifolia (Lavender) Flower Extract,Salvia Sclarea (Clary) Extract,Silica,Sorbitan Isostearate,Panax Ginseng Callus Culture Extract,Glycine,Serine,Glutamic Acid,Centella Asiatica Extract,Citrus Junos Fruit Extract,Myristyl Alcohol,Aspartic Acid,Leucine,Alanine,Lysine,Arginine,Tyrosine,Phenylalanine,Proline,Threonine,Valine,Isoleucine,Histidine,Cysteine,Methionine,Diamond Powder

Section 51945-4

Section 55105-1

skin protectant

Section 55106-9

Hydrogenated Polydecene,Niacinamide


Structured Label Content

Indications and Usage (34067-9)

take proper amount to the skin when needed

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water,Glycerin,Dimethicone,Dipropylene Glycol,1,2-Hexanediol,Glyceryl Stearate,Stearyl Alcohol,Propanediol,Trehalose,Polyglyceryl-2 Stearate,Polysorbate 60,Caprylic/CapricTriglyceride,Cyclopentasiloxane,Olea Europaea (Olive) Fruit Oil,PEG-100 Stearate,Cetyl Alcohol,Sorbitan Olivate,Tromethamine,Fragrance,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Tocopheryl Acetate,Methyl Methacrylate Crosspolymer,Butylene Glycol,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Ethylhexylglycerin,Carbomer,Panthenol,Squalane,

Coptis Japonica Root Extract,Adenosine,Disodium EDTA,Sodium Hyaluronate,Borago Officinalis Extract,Centaurea Cyanus Flower Extract,Chamomilla Recutita (Matricaria) Flower Extract,Hyacinthus Orientalis (Hyacinth) Extract,Lavandula Angustifolia (Lavender) Flower Extract,Salvia Sclarea (Clary) Extract,Silica,Sorbitan Isostearate,Panax Ginseng Callus Culture Extract,Glycine,Serine,Glutamic Acid,Centella Asiatica Extract,Citrus Junos Fruit Extract,Myristyl Alcohol,Aspartic Acid,Leucine,Alanine,Lysine,Arginine,Tyrosine,Phenylalanine,Proline,Threonine,Valine,Isoleucine,Histidine,Cysteine,Methionine,Diamond Powder

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protectant

Section 55106-9 (55106-9)

Hydrogenated Polydecene,Niacinamide


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)