Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 46499995-8b13-3e5c-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Purslane (0.5 g) Niacinamide (2 g) Glycerin (5.93 g) Nelumbo Nucifera Flower (1.35 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-01-01

Description

Glycerin: 5.93 %vv Niacinamide: 2.00 %vv Nelumbo Nucifera Flower Extract: 1.35 %vv Portulaca Oleracea Extract: 0.50 %vv


Medication Information

Warnings and Precautions

1. For external use only.

1) Do not use over the wound and irritated skin with eczema or infections

2) Discontinue using the product if signs of irritations and/or rashes occur and seek professional medical help

2. Keep the cover closed tight after use

3. Do not put the left over contents back into the container to avoid deterioration

1) Avoid contact with eyes

2) Keep out of reach of children

3) Store in a cool and dry place, away from direct sun light

Indications and Usage

After applying a toner in the morning and in the evening, relieve a proper amount, spread it on the face smoothly and evenly from inside to the outside of the face and then gently pat for absorption.

Dosage and Administration

for external use only



Description

Glycerin: 5.93 %vv Niacinamide: 2.00 %vv Nelumbo Nucifera Flower Extract: 1.35 %vv Portulaca Oleracea Extract: 0.50 %vv

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Butylene Glycol, Glycerin, Dipropylene Glycol, 1,2-Hexanediol, Niacinamide, Nelumbo Nucifera Flower Extract, Xylitylglucoside, Anhydroxylitol, Xylitol, Portulaca Oleracea Extract, Saccharide Isomerate, Biosaccharide Gum-1, Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Luffa Cylindrica Fruit Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Ethylhexylglycerin, Hydrogenated Lecithin, Vigna Radiata Seed Extract, Cellulose Gum, Disodium EDTA, Sodium Hyaluronate, Ceramide 3, Glyceryl Acrylate/Acrylic Acid Copolymer, Camellia Sinensis Leaf Extract, Morus Bombycis Root Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract

Section 51945-4

Section 55105-1

Moisturrizer & Skin Conditioning (Protectant)

Section 55106-9

Glycerin: 5.93 %vv

Niacinamide: 2.00 %vv

Nelumbo Nucifera Flower Extract: 1.35 %vv

Portulaca Oleracea Extract: 0.50 %vv


Structured Label Content

Indications and Usage (34067-9)

After applying a toner in the morning and in the evening, relieve a proper amount, spread it on the face smoothly and evenly from inside to the outside of the face and then gently pat for absorption.

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

1. For external use only.

1) Do not use over the wound and irritated skin with eczema or infections

2) Discontinue using the product if signs of irritations and/or rashes occur and seek professional medical help

2. Keep the cover closed tight after use

3. Do not put the left over contents back into the container to avoid deterioration

1) Avoid contact with eyes

2) Keep out of reach of children

3) Store in a cool and dry place, away from direct sun light

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water, Butylene Glycol, Glycerin, Dipropylene Glycol, 1,2-Hexanediol, Niacinamide, Nelumbo Nucifera Flower Extract, Xylitylglucoside, Anhydroxylitol, Xylitol, Portulaca Oleracea Extract, Saccharide Isomerate, Biosaccharide Gum-1, Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Luffa Cylindrica Fruit Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Ethylhexylglycerin, Hydrogenated Lecithin, Vigna Radiata Seed Extract, Cellulose Gum, Disodium EDTA, Sodium Hyaluronate, Ceramide 3, Glyceryl Acrylate/Acrylic Acid Copolymer, Camellia Sinensis Leaf Extract, Morus Bombycis Root Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Moisturrizer & Skin Conditioning (Protectant)

Section 55106-9 (55106-9)

Glycerin: 5.93 %vv

Niacinamide: 2.00 %vv

Nelumbo Nucifera Flower Extract: 1.35 %vv

Portulaca Oleracea Extract: 0.50 %vv


Advanced Ingredient Data


Raw Label Data

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