SPL v1
SPL
SPL Set ID bf97d7b2-fd21-4874-9b07-2bb136a52e0c
Route
TOPICAL
Published
Effective Date 2016-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (11.22 g) Niacinamide (2.50 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-07-01

Description

Active Ingredient: Glycerin 8.98%, Niacinamide 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Glycerin 8.98%, Niacinamide 2.0%

Use

Use: Helps prevent and relieve chapped or cracked skin

Warnings

Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

Directions

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

Active Ingredient

Active Ingredient: Glycerin 8.98%, Niacinamide 2.0%

Inactive Ingredient

Inactive Ingredients: Snail Secretion Filtrate, Water, Hydrogenated Polydecene, Cetyl Ethylhexanoate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cyclopentasiloxane, Macadamia Ternifolia Seed Oil, Cetearyl Alcohol, Hydrogenated Vegetable Oil, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Cyclohexasiloxane, Betaine, Palmitic Acid, Carbomer, Polyacrylate-13, Stearic Acid, Tromethamine, Phenoxyethanol, Dimethicone, Tocopheryl Acetate, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Caprylyl Glycol, Xanthan Gum, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Polysorbate 20, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Sorbitan Isostearate, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Rosa Canina Fruit Oil, Citrus aurantium dulcis (orange) peel oil, Citrus Aurantifolia (Lime) Oil, Camellia Japonica Flower Extract, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Gold, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Gardenia Jasminoides Fruit Extract, Opuntia Coccinellifera Fruit Extract, Citric Acid, rh-Polypeptide-22

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Use

Use: Helps prevent and relieve chapped or cracked skin

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

Directions

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Glycerin 8.98%, Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Snail Secretion Filtrate, Water, Hydrogenated Polydecene, Cetyl Ethylhexanoate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cyclopentasiloxane, Macadamia Ternifolia Seed Oil, Cetearyl Alcohol, Hydrogenated Vegetable Oil, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Cyclohexasiloxane, Betaine, Palmitic Acid, Carbomer, Polyacrylate-13, Stearic Acid, Tromethamine, Phenoxyethanol, Dimethicone, Tocopheryl Acetate, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Caprylyl Glycol, Xanthan Gum, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Polysorbate 20, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Sorbitan Isostearate, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Rosa Canina Fruit Oil, Citrus aurantium dulcis (orange) peel oil, Citrus Aurantifolia (Lime) Oil, Camellia Japonica Flower Extract, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Gold, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Gardenia Jasminoides Fruit Extract, Opuntia Coccinellifera Fruit Extract, Citric Acid, rh-Polypeptide-22

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

All Sections (JSON)