d53dc610-9fd4-450c-a159-0a97dcabd59a

SPL v1
SPL
SPL Set ID d53dc610-9fd4-450c-a159-0a97dcabd59a
Route
topical
Published
Effective Date 2016-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
niacinamide (0.90 g) dimethicone (0.22 g)
Inactive Ingredients
water panthenol

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2016-07-01

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Niacinamide 2.0%, Dimethicone 0.5%


Medication Information

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

Purpose

Purpose: Skin Protectant

Directions

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

Description

Active Ingredient: Niacinamide 2.0%, Dimethicone 0.5%

Use

Use: Helps prevent and relieve chapped or cracked skin

Active Ingredient

Active Ingredient: Niacinamide 2.0%, Dimethicone 0.5%

Inactive Ingredient

Inactive Ingredients: Snail Secretion Filtrate, Macadamia Ternifolia Seed Oil, Hydrogenated Polydecene, Water, Cetearyl Alcohol, Cetyl Ethylhexanoate, Glycol Stearate SE, Panthenol, Caprylic/Capric Triglyceride, Octyldodecyl Myristate, Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Glyceryl Stearate, Beeswax, Sodium Polyacrylate, PEG-100 Stearate, Cyclopentasiloxane, Ethylhexyl Stearate, Glycerin, Palmitic Acid, Stearic Acid, Hydrogenated Lecithin, Phenoxyethanol, Chlorphenesin, Propanediol, Ethylhexylglycerin, Tocopheryl Acetate, Caprylyl Glycol, Dimethiconol, Laureth-23, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Trideceth-6, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Alcohol, Citrus aurantium dulcis (orange) peel oil, Beta-Glucan, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Sodium Hyaluronate, Eucalyptus Globulus Leaf Oil, Gold, Butylene Glycol, Camellia Japonica Flower Extract, Citric Acid, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Gardenia Jasminoides Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Opuntia Coccinellifera Fruit Extract, rh-Polypeptide-22

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

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

Purpose (PURPOSE)

Purpose: Skin Protectant

Directions

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

Use

Use: Helps prevent and relieve chapped or cracked skin

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Niacinamide 2.0%, Dimethicone 0.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Snail Secretion Filtrate, Macadamia Ternifolia Seed Oil, Hydrogenated Polydecene, Water, Cetearyl Alcohol, Cetyl Ethylhexanoate, Glycol Stearate SE, Panthenol, Caprylic/Capric Triglyceride, Octyldodecyl Myristate, Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Glyceryl Stearate, Beeswax, Sodium Polyacrylate, PEG-100 Stearate, Cyclopentasiloxane, Ethylhexyl Stearate, Glycerin, Palmitic Acid, Stearic Acid, Hydrogenated Lecithin, Phenoxyethanol, Chlorphenesin, Propanediol, Ethylhexylglycerin, Tocopheryl Acetate, Caprylyl Glycol, Dimethiconol, Laureth-23, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Trideceth-6, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Alcohol, Citrus aurantium dulcis (orange) peel oil, Beta-Glucan, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Sodium Hyaluronate, Eucalyptus Globulus Leaf Oil, Gold, Butylene Glycol, Camellia Japonica Flower Extract, Citric Acid, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Gardenia Jasminoides Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Opuntia Coccinellifera Fruit Extract, 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

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