SPL v1
SPL
SPL Set ID 0be5f72e-f80e-6cfa-e063-6394a90a3fc3
Route
TOPICAL
Published
Effective Date 2023-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (20 g)
Inactive Ingredients
Water Centella Asiatica

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-12-01

Description

Niacinamide


Medication Information

Warnings and Precautions

1. During using product or after use, if there are any

abnormal symptoms or side effects such as red spots,

swelling or itching in the area of use due to direct

sunlight, consult with a specialist.

2. Refrain from using on areas with scars, etc.

3. Precautions for storage and handling

A) Keep out of reach of chil

dren

B) Store away from direct sunlight

4.

Since a high dose of niacinamide is prescribed, please

adjust the amount after performing a skin sensitivity test

when using for the first time

Indications and Usage

After preparing the skin texture with toner, gently spread it over the enlarged pores and let it absorb.

Dosage and Administration

topical use only

Description

Niacinamide

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Butylene Glycol

1,2-Hexanediol

Zinc PCA

Olea Europaea (Olive) Fruit Extract

Centella Asiatica Extract

Portulaca Oleracea Extract

Chamomilla Recutita (Matricaria) Flower Extract

Salvia Officinalis (Sage) Leaf Extract

Rosmarinus Officinalis (Rosemary) Leaf Extract

Salix Alba (Willow) Bark Extract

Melaleuca Alternifolia (Tea Tree) Extract

Tremella Fuciformis (Mushroom) Extract

Nelumbo Nucifera Flower Extract

Hamamelis Virginiana (Witch Hazel) Water

Glycerin

Sodium Hyaluronate

Caprylyl Glycol

Allantoin

Disodium EDTA

Ethylhexylglycerin

Section 51945-4

Section 55105-1

skin protect

Section 55106-9

Niacinamide


Structured Label Content

Indications and Usage (34067-9)

After preparing the skin texture with toner, gently spread it over the enlarged pores and let it absorb.

Dosage and Administration (34068-7)

topical use only

Warnings and Precautions (34071-1)

1. During using product or after use, if there are any

abnormal symptoms or side effects such as red spots,

swelling or itching in the area of use due to direct

sunlight, consult with a specialist.

2. Refrain from using on areas with scars, etc.

3. Precautions for storage and handling

A) Keep out of reach of chil

dren

B) Store away from direct sunlight

4.

Since a high dose of niacinamide is prescribed, please

adjust the amount after performing a skin sensitivity test

when using for the first time

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Butylene Glycol

1,2-Hexanediol

Zinc PCA

Olea Europaea (Olive) Fruit Extract

Centella Asiatica Extract

Portulaca Oleracea Extract

Chamomilla Recutita (Matricaria) Flower Extract

Salvia Officinalis (Sage) Leaf Extract

Rosmarinus Officinalis (Rosemary) Leaf Extract

Salix Alba (Willow) Bark Extract

Melaleuca Alternifolia (Tea Tree) Extract

Tremella Fuciformis (Mushroom) Extract

Nelumbo Nucifera Flower Extract

Hamamelis Virginiana (Witch Hazel) Water

Glycerin

Sodium Hyaluronate

Caprylyl Glycol

Allantoin

Disodium EDTA

Ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protect

Section 55106-9 (55106-9)

Niacinamide


Advanced Ingredient Data


Raw Label Data

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