SPL v1
SPL
SPL Set ID ba3f0442-f3a7-6e3f-e053-2a95a90af13a
Route
TOPICAL
Published
Effective Date 2021-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (46 g) Glycerin (2 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-01-01

Description

Glycerin, Niacinamide


Medication Information

Warnings and Precautions

1. If any of the following Symptoms occur, Cease use immediately. Continued usage would exacerbate the



symptoms. If symptoms persist, consult a doctor.



1) During of after usage, if red spots appear or you suffer from welling or itching or any other abnormal



symptoms after direct exposure to sunlight, consult a doctor immediately.



2)Avoid usage on cuts and wounds.



3) Storage and usage precautions.



A) Keep it out of reach of children.



B) Avoid exposure to direct sunlight during storage.

Indications and Usage

Apply a small amount of cream on the face and gently pat the skin.

Dosage and Administration

For external use only

Description

Glycerin, Niacinamide

Section 50565-1

Keep out of reach of the children

Section 51727-6

Water, etc

Section 51945-4

Section 55105-1

Skin Protectant - Anti-Wrinkle, Whitening

Section 55106-9

Glycerin, Niacinamide


Structured Label Content

Indications and Usage (34067-9)

Apply a small amount of cream on the face and gently pat the skin.

Dosage and Administration (34068-7)

For external use only

Warnings and Precautions (34071-1)

1. If any of the following Symptoms occur, Cease use immediately. Continued usage would exacerbate the



symptoms. If symptoms persist, consult a doctor.



1) During of after usage, if red spots appear or you suffer from welling or itching or any other abnormal



symptoms after direct exposure to sunlight, consult a doctor immediately.



2)Avoid usage on cuts and wounds.



3) Storage and usage precautions.



A) Keep it out of reach of children.



B) Avoid exposure to direct sunlight during storage.

Section 50565-1 (50565-1)

Keep out of reach of the children

Section 51727-6 (51727-6)

Water, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant - Anti-Wrinkle, Whitening

Section 55106-9 (55106-9)

Glycerin, Niacinamide


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)