Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4b5dd7b0-0ebc-7076-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-08-26
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 2017-03-01
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

4. Use as avoiding eye areas.

Indications and Usage
  • Refine skin with using a toner after cleansing face.
  • Apply mask on the face and take a rest 10-20 minutes.
  • Remove mask and gently pat remaining essence until fully absorbed.
Dosage and Administration

for external use only



Description

Niacinamide

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Glycerin, Sodium Hyaluronate, Butylene Glycol, Pearl Extract, Hydrolyzed Hyaluronic Acid, Hyaluronic Acid, Glutathione, etc.

Section 51945-4

Section 55105-1

Skin Protectant - Whitening

Section 55106-9

Niacinamide

Structured Label Content

Indications and Usage (34067-9)
  • Refine skin with using a toner after cleansing face.
  • Apply mask on the face and take a rest 10-20 minutes.
  • Remove mask and gently pat remaining essence until fully absorbed.
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

4. Use as avoiding eye areas.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water, Glycerin, Sodium Hyaluronate, Butylene Glycol, Pearl Extract, Hydrolyzed Hyaluronic Acid, Hyaluronic Acid, Glutathione, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant - 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: 2026-02-15T11:56:17.405209 · Updated: 2026-03-14T22:54:40.661795