SPL v2
SPL
SPL Set ID 3cf718cb-535c-4f03-bd47-ea26160f2861
Route
TOPICAL
Published
Effective Date 2014-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (20 mg)
Inactive Ingredients
Water Dipropylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-04-01

Description

Active Ingredient: Glycerin 20%

Purpose

Purpose: Skin Portectant


Medication Information

Purpose

Purpose: Skin Portectant

Description

Active Ingredient: Glycerin 20%

Warnings

Warnings:

1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :

1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.

2. Do not apply the product to wounds or skin with dermatitis such as eczema.

3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.

Active Ingredient

Active Ingredient: Glycerin 20%

Inactive Ingredient

Inactive Ingredients:

Water, Hydrogenated Polydecene, Dipropylene Glycol, Macadamia Integrifolia Seed Oil, Butylene Glycol, Cyclohexasiloxane, Betaine, Limnanthes Alba (Meadowfoam) Seed Oil, Stearic Acid, Glyceryl Stearate SE, Cyclopentasiloxane, Dimethiconol, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Arctium Lappa Root Extract, Artemisia Capillaris Leaf Extract, Calendula Officinalis Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Ocimum Basilicum (Basil) Leaf Extract, Oenothera Biennis (Evening Primrose) Seed Extract, Perilla Frutescens Leaf Extract, Prunus Mume Fruit Extract, Thymus Vulgaris (Thyme) Extract, 1,2-Hexanediol, Portulaca Oleracea Extract, Hydrolyzed Collagen, Beta-Glucan, Ceramide 3, Raffinose, Palmitoyl Pentapeptide-4, Glyceryl Stearate, Olivoyl Hydrolyzed Wheat Protein, Cetearyl Alcohol, Glyceryl Oleate, Caprylic/Capric Glycerides, Dimethicone, Citrus Paradisi (Grapefruit) Fruit Extract, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance, Potassium Hydroxide, Disodium EDTA, Xanthan Gum

Indications & Usage

Indication and usage:

1) Tighten the lid after using it.

2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

3) Use it in the morning or evening after shower.

Dosage & Administration

Dosage and administration:

Take appropriate amount to the entire face and body, gently massage and tapping until absorbed.

Keep Out of Reach of Children

Keep out of reach of babies and children.

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Portectant

Warnings (WARNINGS)

Warnings:

1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :

1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.

2. Do not apply the product to wounds or skin with dermatitis such as eczema.

3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Glycerin 20%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water, Hydrogenated Polydecene, Dipropylene Glycol, Macadamia Integrifolia Seed Oil, Butylene Glycol, Cyclohexasiloxane, Betaine, Limnanthes Alba (Meadowfoam) Seed Oil, Stearic Acid, Glyceryl Stearate SE, Cyclopentasiloxane, Dimethiconol, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Arctium Lappa Root Extract, Artemisia Capillaris Leaf Extract, Calendula Officinalis Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Ocimum Basilicum (Basil) Leaf Extract, Oenothera Biennis (Evening Primrose) Seed Extract, Perilla Frutescens Leaf Extract, Prunus Mume Fruit Extract, Thymus Vulgaris (Thyme) Extract, 1,2-Hexanediol, Portulaca Oleracea Extract, Hydrolyzed Collagen, Beta-Glucan, Ceramide 3, Raffinose, Palmitoyl Pentapeptide-4, Glyceryl Stearate, Olivoyl Hydrolyzed Wheat Protein, Cetearyl Alcohol, Glyceryl Oleate, Caprylic/Capric Glycerides, Dimethicone, Citrus Paradisi (Grapefruit) Fruit Extract, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance, Potassium Hydroxide, Disodium EDTA, Xanthan Gum

Indications & Usage (INDICATIONS & USAGE)

Indication and usage:

1) Tighten the lid after using it.

2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

3) Use it in the morning or evening after shower.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage and administration:

Take appropriate amount to the entire face and body, gently massage and tapping until absorbed.

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

Keep out of reach of babies and children.

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


Advanced Ingredient Data


Raw Label Data

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