SPL v1
SPL
SPL Set ID 6f8348fb-6ab5-4d8e-a49b-f60289f3b357
Route
TOPICAL
Published
Effective Date 2016-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (4.8 g)
Inactive Ingredients
Chamomile Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-01-02

Description

Active Ingredient: Glycerin 6.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Glycerin 6.0%

Usage

Usage: Spray over the face at an appropriate distance 2 ~ 3 times.

Warnings

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

Active Ingredient

Active Ingredient: Glycerin 6.0%

Inactive Ingredient

Inactive Ingredients: Chamomilla Recutita (Matricaria) Flower, Water, Chamomilla Recutita (Matricaria) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Centella Asiatica Extract, Glycine Max (Soybean) Seed Extract, Glycerin, Butylene Glycol, Hydrolyzed Collagen, Sodium Hyaluronate, Dioscorea Opposita (Wild Yam) Root Extract, Aloe Barbadensis Leaf Juice, Betaine, Lonicera Japonica (Honeysuckle) Flower Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Glycosyl Trehalose, Hydrogenated Starch Hydrolysate, Eclipta Prostrata Extract, Rehmannia Chinensis Root Extract, Artemisia Princeps Leaf Extract, Portulaca Oleracea Extract, PEG-60 Hydrogenated Castor Oil, Adenosine, Disodium EDTA, Flavor, Mentol

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Usage

Usage: Spray over the face at an appropriate distance 2 ~ 3 times.

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Glycerin 6.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Chamomilla Recutita (Matricaria) Flower, Water, Chamomilla Recutita (Matricaria) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Centella Asiatica Extract, Glycine Max (Soybean) Seed Extract, Glycerin, Butylene Glycol, Hydrolyzed Collagen, Sodium Hyaluronate, Dioscorea Opposita (Wild Yam) Root Extract, Aloe Barbadensis Leaf Juice, Betaine, Lonicera Japonica (Honeysuckle) Flower Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Glycosyl Trehalose, Hydrogenated Starch Hydrolysate, Eclipta Prostrata Extract, Rehmannia Chinensis Root Extract, Artemisia Princeps Leaf Extract, Portulaca Oleracea Extract, PEG-60 Hydrogenated Castor Oil, Adenosine, Disodium EDTA, Flavor, Mentol

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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