SPL v2
SPL
SPL Set ID b5bf52b1-9880-971b-e053-2a95a90a9f4f
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 2020-12-06

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

Glycerin

Butylene Glycol

Caprylic/Capric Triglyceride

Cyclopentasiloxane,Cyclohexasiloxane

Glyceryl Stearate, PEG-100 Stearate

Panax Ginseng Leaf/Root/Stem Extract

Sorbitan Stearate

1,2-hexanediol, Caprylyl Glycol

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Cetyl Alcohol

Stearic Acid

Glyceryl Stearate SE

Polysorbate 60

Dimethicone

Squalane

Arginine

Sodium Hyaluronate

Adenosine

Tocopheryl Acetate

Disodium EDTA

Allantoin

Xanthan Gum

Section 51945-4

Section 55105-1

Wrinkle Improvement• Whitening effects

Anti-inflammatory effects, anti-acid effects (anti-oxidation effects)

Anti-aging effects on skin

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

Glycerin

Butylene Glycol

Caprylic/Capric Triglyceride

Cyclopentasiloxane,Cyclohexasiloxane

Glyceryl Stearate, PEG-100 Stearate

Panax Ginseng Leaf/Root/Stem Extract

Sorbitan Stearate

1,2-hexanediol, Caprylyl Glycol

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Cetyl Alcohol

Stearic Acid

Glyceryl Stearate SE

Polysorbate 60

Dimethicone

Squalane

Arginine

Sodium Hyaluronate

Adenosine

Tocopheryl Acetate

Disodium EDTA

Allantoin

Xanthan Gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Wrinkle Improvement• Whitening effects

Anti-inflammatory effects, anti-acid effects (anti-oxidation effects)

Anti-aging effects on skin

Section 55106-9 (55106-9)

niacinamide


Advanced Ingredient Data


Raw Label Data

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