SPL v1
SPL
SPL Set ID 685b0e09-802d-7125-e053-2991aa0a0987
Route
ORAL
Published
Effective Date 2018-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (5.05 g)
Inactive Ingredients
Niacinamide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-03-27
Description

glycerin

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

apply proper amount to the skin

Dosage and Administration

for external use only

Description

glycerin

Section 50565-1

Keep out of reach of children.

Section 51727-6

water, butylene glycol, betaine, niacinamide, etc

Section 51945-4

Section 55105-1

whitening, anti wrinkle

Section 55106-9

glycerin

Structured Label Content

Indications and Usage (34067-9)

apply proper amount to the 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

4. Use as avoiding eye areas.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

water, butylene glycol, betaine, niacinamide, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

whitening, anti wrinkle

Section 55106-9 (55106-9)

glycerin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:32.355841 · Updated: 2026-03-14T22:55:04.352870