SPL v1
SPL
SPL Set ID 0185e1ff-22a6-2daa-e063-6394a90a5d36
Route
VAGINAL
Published
Effective Date 2023-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (3 g)
Inactive Ingredients
Allantoin Glycerin Water Centella Asiatica

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-07-01

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 children

B) Store away from direct sunlight

Indications and Usage

After showering, wipe off excess water and spray the product evenly 2-3 times on the desired area (except the face) at a distance of 15-20cm.

Dosage and Administration

topical use only

Description

Niacinamide

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Glycolic Acid

Butylene Glycol

1,2-Hexanediol

Betaine Salicylate

Salicylic Acid

Alpha-Arbutin

Dipropylene Glycol

Menthol

Glutathione

Betaine

Allantoin

Camellia Sinensis Leaf Extract

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

Glycerin

Melaleuca Alternifolia (Tea Tree) Leaf Oil

Alcohol Denat.

PEG-60 Hydrogenated Castor Oil

Sodium Hyaluronate

Disodium EDTA

Ethylhexylglycerin

Section 51945-4

Section 55105-1

skin protect

Section 55106-9

Niacinamide


Structured Label Content

Indications and Usage (34067-9)

After showering, wipe off excess water and spray the product evenly 2-3 times on the desired area (except the face) at a distance of 15-20cm.

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 children

B) Store away from direct sunlight

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Glycolic Acid

Butylene Glycol

1,2-Hexanediol

Betaine Salicylate

Salicylic Acid

Alpha-Arbutin

Dipropylene Glycol

Menthol

Glutathione

Betaine

Allantoin

Camellia Sinensis Leaf Extract

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

Glycerin

Melaleuca Alternifolia (Tea Tree) Leaf Oil

Alcohol Denat.

PEG-60 Hydrogenated Castor Oil

Sodium Hyaluronate

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

All Sections (JSON)