SPL v2
SPL
SPL Set ID a3cca7ab-1f18-f7fa-e053-2a95a90a2c60
Route
TOPICAL
Published
Effective Date 2020-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (2 g)
Inactive Ingredients
Water Hyaluronate Sodium Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-04-04

Description

niacinamide


Medication Information

Warnings and Precautions

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

Indications and Usage

apply proper amount to the skin

Dosage and Administration

for external use only

Description

niacinamide

Section 50565-1

• Keep Out of Reach of Children.

Section 51727-6

Water

Dipropylene Glycol

Glycerin

Propylene Glycol

Cyclopentasiloxane,Cyclohexasiloxane

Cetearyl Alcohol

Neopentyl Glycol Dicaprate

Betaine

Caprylic/Capric Triglyceride

Cetyl Ethylhexanoate

Cetearyl Olivate, Sorbitan Olivate

Panax Ginseng Leaf/Root/Stem Extract

Glyceryl Stearate SE

Bees Wax

Sorbitan Stearate

Polyacrylate-13, Polyisobutene, Polysorbate20

Sodium Hyaluronate

1,2-hexanediol, Caprylyl Glycol

Stearic Acid

Dimethicone

Squalane

Fragrance

Disodium EDTA

Section 51945-4

Section 55105-1

Moisturizing effects

Whitening effects

Anti-inflammatory effects, antacid effects Anti-aging effects on skin (anti-oxidation effects)

Section 55106-9

niacinamide


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)

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

Section 50565-1 (50565-1)

• Keep Out of Reach of Children.

Section 51727-6 (51727-6)

Water

Dipropylene Glycol

Glycerin

Propylene Glycol

Cyclopentasiloxane,Cyclohexasiloxane

Cetearyl Alcohol

Neopentyl Glycol Dicaprate

Betaine

Caprylic/Capric Triglyceride

Cetyl Ethylhexanoate

Cetearyl Olivate, Sorbitan Olivate

Panax Ginseng Leaf/Root/Stem Extract

Glyceryl Stearate SE

Bees Wax

Sorbitan Stearate

Polyacrylate-13, Polyisobutene, Polysorbate20

Sodium Hyaluronate

1,2-hexanediol, Caprylyl Glycol

Stearic Acid

Dimethicone

Squalane

Fragrance

Disodium EDTA

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Moisturizing effects

Whitening effects

Anti-inflammatory effects, antacid effects Anti-aging effects on skin (anti-oxidation effects)

Section 55106-9 (55106-9)

niacinamide


Advanced Ingredient Data


Raw Label Data

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