SPL v1
SPL
SPL Set ID 87f8ec30-f4c7-45a1-a5d9-99a80ffdd09f
Route
TOPICAL
Published
Effective Date 2013-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (20 mg) Allantoin (0.6 mg)
Inactive Ingredients
Water Butylene Glycol Triethylhexanoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-01

Description

Active ingredients: Glycerin 20%, Allantoin 0.6%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredients: Glycerin 20%, Allantoin 0.6%

Warnings

Warnings:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema.

Active Ingredient

Active ingredients: Glycerin 20%, Allantoin 0.6%

Inactive Ingredient

Inactive ingredients:

Betula Platyphylla Japonica Juice, Cyclomethicone, Butylene Glycol, Triethylhexanoin, Dicaprylyl Carbonate, Polydecene, Niacinamide, Caprylic/Capric Triglyceride, Peg/Ppg-17/6 Copolymer, Sodium Hyaluronate, Sodium Chloride, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Polysorbate 20, Panthenol, Trehalose, Beta Glucan, Adenosine, Goat Milk Extract, Milk Protein, Sodium Pca, Betain, Sorbitol, Glycine, Alanine, Proline, Serine, Threonine, Arginine, Lysine, Glutamic Acid, Biosaccharide Gum-1, Glycyrrhiza Glabra(Licorice) Root Extract, Cereus Grandiflorus(Cactus)Flower Extract, Adansonia Digitata Seed Extract,Paeonia Albiflora Root Extract, Convallaria Majalis Root Extract, Magnolia Liliflora Flower Extract, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Euterpe Oleracrea Fruit Extract, Rubus Fruticosus (Blackberry) Fruit, Sambucus Nigra Fruit Extract, Brassica Oleracea Italica (Broccoli) Extract, Medicago Sativa (Alfalfa) Extract, Brassica Oleracea Capitata (Cabbage) Leaf Extract, Triticum Vulgare (Wheat) Germ Extract, Brassica Campestris (Rapeseed) Extract, Raphanus Sativus (Radish) Seed Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii(Shea Butter), Limnanthes Alba (Meadowfoam) Seed Oil, Simmondsia Chinensis(Jojoba) Seed Oil, Hydrolyzed Lycium Barbarum Fruit Extract, Vaccinium Macrocaron (Cranberry) Fruit Extract, Fragrance

Indications and Usage

Indications and Usage:

1. Always replace cap after use

2. Keep away from direct sunlight or heat.

Dosage and Administration

Dosage and Administration:

After washing your face, spray onto skin evenly, tapping lighting to aid absorption.

Before using, shake the bottle lightly to combine ingredients which have naturally separated.

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


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Glycerin 20%, Allantoin 0.6%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Betula Platyphylla Japonica Juice, Cyclomethicone, Butylene Glycol, Triethylhexanoin, Dicaprylyl Carbonate, Polydecene, Niacinamide, Caprylic/Capric Triglyceride, Peg/Ppg-17/6 Copolymer, Sodium Hyaluronate, Sodium Chloride, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Polysorbate 20, Panthenol, Trehalose, Beta Glucan, Adenosine, Goat Milk Extract, Milk Protein, Sodium Pca, Betain, Sorbitol, Glycine, Alanine, Proline, Serine, Threonine, Arginine, Lysine, Glutamic Acid, Biosaccharide Gum-1, Glycyrrhiza Glabra(Licorice) Root Extract, Cereus Grandiflorus(Cactus)Flower Extract, Adansonia Digitata Seed Extract,Paeonia Albiflora Root Extract, Convallaria Majalis Root Extract, Magnolia Liliflora Flower Extract, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Euterpe Oleracrea Fruit Extract, Rubus Fruticosus (Blackberry) Fruit, Sambucus Nigra Fruit Extract, Brassica Oleracea Italica (Broccoli) Extract, Medicago Sativa (Alfalfa) Extract, Brassica Oleracea Capitata (Cabbage) Leaf Extract, Triticum Vulgare (Wheat) Germ Extract, Brassica Campestris (Rapeseed) Extract, Raphanus Sativus (Radish) Seed Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii(Shea Butter), Limnanthes Alba (Meadowfoam) Seed Oil, Simmondsia Chinensis(Jojoba) Seed Oil, Hydrolyzed Lycium Barbarum Fruit Extract, Vaccinium Macrocaron (Cranberry) Fruit Extract, Fragrance

Indications and Usage (INDICATIONS AND USAGE)

Indications and Usage:

1. Always replace cap after use

2. Keep away from direct sunlight or heat.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and Administration:

After washing your face, spray onto skin evenly, tapping lighting to aid absorption.

Before using, shake the bottle lightly to combine ingredients which have naturally separated.

Keep Out of Reach of Children (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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