SPL v2
SPL
SPL Set ID 24c05259-f732-49d5-b3b2-06d2e3bb9b2d
Route
TOPICAL
Published
Effective Date 2014-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (24 g)
Inactive Ingredients
Water Propanediol

Identifiers & Packaging

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

Description

Active Ingredient: Glycerin 20%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

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, Propanediol, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Diisostearyl Malate, 1,2-Hexanediol, Tri-C14-15 Alkyl Citrate, Neopentyl Glycol Diheptanoate, Imperata Cylindrica Root Extract, Leuconostoc/Radish Root Ferment Filtrate, Polyglutamic Acid, Trehalose, Viscum Album (Mistletoe) Leaf Extract, Cyclopentasiloxane, Dimethiconol, Olivoyl Hydrolyzed Wheat Protein, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Oleate, Glyceryl Stearate, Hydrogenated Lecithin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cyclomethicone, Dimethicone, Butylene Glycol, C18-21 Alkane, Sodium Polyacrylate, Trideceth-6, Zinc, Ceramide 3, Cholesterol, Potassium Hydroxide, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Centella Asiatica Extract, Ethoxydiglycol, Musa Sapientum (Banana) Fruit Extract, Citric Acid, Arginine, Lactobacillus/Soybean Ferment Extract, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Panax Ginseng Callus Culture Extract, Phellinus Linteus Mycelium Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Polygonum Cuspidatum Root Extract, Rosmarinus Offcinalis (Rosemary) Leaf Extract, Scutellaria Baicalensis Root Extract, Squalane, Disodium EDTA

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 Protectant

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, Propanediol, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Diisostearyl Malate, 1,2-Hexanediol, Tri-C14-15 Alkyl Citrate, Neopentyl Glycol Diheptanoate, Imperata Cylindrica Root Extract, Leuconostoc/Radish Root Ferment Filtrate, Polyglutamic Acid, Trehalose, Viscum Album (Mistletoe) Leaf Extract, Cyclopentasiloxane, Dimethiconol, Olivoyl Hydrolyzed Wheat Protein, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Oleate, Glyceryl Stearate, Hydrogenated Lecithin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cyclomethicone, Dimethicone, Butylene Glycol, C18-21 Alkane, Sodium Polyacrylate, Trideceth-6, Zinc, Ceramide 3, Cholesterol, Potassium Hydroxide, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Centella Asiatica Extract, Ethoxydiglycol, Musa Sapientum (Banana) Fruit Extract, Citric Acid, Arginine, Lactobacillus/Soybean Ferment Extract, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Panax Ginseng Callus Culture Extract, Phellinus Linteus Mycelium Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Polygonum Cuspidatum Root Extract, Rosmarinus Offcinalis (Rosemary) Leaf Extract, Scutellaria Baicalensis Root Extract, Squalane, Disodium EDTA

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

All Sections (JSON)