SPL v1
SPL
SPL Set ID 70101b1b-6e41-4ccf-b350-ed378822f523
Route
TOPICAL
Published
Effective Date 2016-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (2.5 g)
Inactive Ingredients
Lavandula Angustifolia Flower Ethylhexyl Palmitate

Identifiers & Packaging

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

Description

Active Ingredient: Glycerin 5.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Glycerin 5.0%

Usage

Usage: Take an appropriate amount and gently apply it on the face

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 5.0%

Inactive Ingredient

Inactive Ingredients: Lavandula Angustifolia (Lavender) Water, Ethylhexyl Palmitate, Allium Cepa (Onion) Bulb Extract, Helianthus Annuus (Sunflower) Seed Oil, Dimethyl Sulfone, Cetearyl Alcohol, 1,2-Hexanediol, Stearic Acid/Behenyl Alcohol/Ceteareth-10/Cetearyl Alcohol, Bacillus/Houttuynia Cordata Extract Ferment Filtrate, Sophora Angustifolia Root Extract, Chrysanthellum Indicum Extract, actobacillus/Camellia Sinensis Leaf Ferment Filtrate, Lactobacillus/Honeysuckle Flower Extract Ferment Filtrate, Lactobacillus/Punica Granatum Fruit Ferment Extract, Aspergillus/Camellia Sinensis Leaf Extract Ferment Filtrate, Ecklonia Cava Extract, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Microcrystalline Wax, Dimethicone, Piper Methysticum Leaf/Root/Stem Extract, Caffeoyl Tripeptide-1, Arginine, Tocopheryl Acetate, Carbomer, Xanthan Gum, Menthol, Rosmarinus Officinalis (Rosemary) Leaf Oil

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Usage

Usage: Take an appropriate amount and gently apply it on the face

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 5.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Lavandula Angustifolia (Lavender) Water, Ethylhexyl Palmitate, Allium Cepa (Onion) Bulb Extract, Helianthus Annuus (Sunflower) Seed Oil, Dimethyl Sulfone, Cetearyl Alcohol, 1,2-Hexanediol, Stearic Acid/Behenyl Alcohol/Ceteareth-10/Cetearyl Alcohol, Bacillus/Houttuynia Cordata Extract Ferment Filtrate, Sophora Angustifolia Root Extract, Chrysanthellum Indicum Extract, actobacillus/Camellia Sinensis Leaf Ferment Filtrate, Lactobacillus/Honeysuckle Flower Extract Ferment Filtrate, Lactobacillus/Punica Granatum Fruit Ferment Extract, Aspergillus/Camellia Sinensis Leaf Extract Ferment Filtrate, Ecklonia Cava Extract, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Microcrystalline Wax, Dimethicone, Piper Methysticum Leaf/Root/Stem Extract, Caffeoyl Tripeptide-1, Arginine, Tocopheryl Acetate, Carbomer, Xanthan Gum, Menthol, Rosmarinus Officinalis (Rosemary) Leaf Oil

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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