Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID a4dd7c53-62cd-6c21-e053-2a95a90a56ea
Route
TOPICAL
Published
Effective Date 2020-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (4 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-05-02
Description

niacinamide

Medication Information

Warnings and Precautions

1) Please consult your doctor if you experience side effects such as swelling, itching, or reddening on the area where you applied the cream.

2) Do not apply on wounds or cuts. 3) Do not store where children may reach, and avoid keeping it exposed to direct sunlight.

Indications and Usage

apply to the face and keep more than 30 minites, and remove

Dosage and Administration

external use only

Description

niacinamide

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

water, glycerin, etc

Section 51945-4

Section 55105-1

wrinkle care

Section 55106-9

niacinamide

Structured Label Content

Indications and Usage (34067-9)

apply to the face and keep more than 30 minites, and remove

Dosage and Administration (34068-7)

external use only

Warnings and Precautions (34071-1)

1) Please consult your doctor if you experience side effects such as swelling, itching, or reddening on the area where you applied the cream.

2) Do not apply on wounds or cuts. 3) Do not store where children may reach, and avoid keeping it exposed to direct sunlight.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

water, glycerin, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

wrinkle care

Section 55106-9 (55106-9)

niacinamide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:26.377524 · Updated: 2026-03-14T22:56:37.078705