Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 59fc4d3e-b555-44df-bb1a-60c7a9eac3fd
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (2 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-08-11
Description

NIACINAMIDE

Medication Information

Warnings and Precautions

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

Indications and Usage

Take appropriate amount and apply evenly to skin

Dosage and Administration

for external use only

Description

NIACINAMIDE

Section 50565-1

keep out of reach of the children

Section 51727-6

Water,Butylene Glycol,Glycerin,Dimethicone,Panthenol,Titanium Dioxide (CI 77891),Niacinamide,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glutathione, Cyclopentasiloxane,Isohexadecane,Sodium Polyacrylate,Ethylhexyl Stearate,Polysorbate 80,Dimethiconol,Betaine,Triethoxycaprylylsilane,Trideceth-6,Pantolactone,Disodium EDTA,Phenoxyethanol,Chlorphenesin,Caprylyl Glycol,Ethylhexylglycerin,Fragrance

Section 51945-4

Section 55105-1

Helps skin whitening

Section 55106-9

NIACINAMIDE

Structured Label Content

Indications and Usage (34067-9)

Take appropriate amount and apply evenly to skin

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water,Butylene Glycol,Glycerin,Dimethicone,Panthenol,Titanium Dioxide (CI 77891),Niacinamide,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glutathione, Cyclopentasiloxane,Isohexadecane,Sodium Polyacrylate,Ethylhexyl Stearate,Polysorbate 80,Dimethiconol,Betaine,Triethoxycaprylylsilane,Trideceth-6,Pantolactone,Disodium EDTA,Phenoxyethanol,Chlorphenesin,Caprylyl Glycol,Ethylhexylglycerin,Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps skin whitening

Section 55106-9 (55106-9)

NIACINAMIDE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:09.213423 · Updated: 2026-03-14T22:54:24.786834