aa6c495e-713d-43cf-b554-ef15d1f47090

SPL v1
SPL
SPL Set ID aa6c495e-713d-43cf-b554-ef15d1f47090
Route
topical
Published
Effective Date 2016-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
niacinamide (1.1 g)
Inactive Ingredients
methylpropanediol cyclomethicone

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2016-05-01

Purpose

Purpose: Skin Protectant

Description

Active ingredient: Niacinamide 2.00%


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: - Gently apply an appropriate amount to the skin. - Apply in daily skin care routine

Description

Active ingredient: Niacinamide 2.00%

Use

Use: helps prevent and relieve chapped or cracked skin

Active Ingredient

Active ingredient: Niacinamide 2.00%

Inactive Ingredient

Inactive Ingredient: Prunus Yedoensis Flower Extract, Methylpropanediol, Cyclomethicone, Hydrogenated Ethylhexyl Olivate, PPG-14 Butyl Ether, C14-22 Alcohols, Olea Europaea (Olive) Fruit Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Pelargonium Graveolens Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Cymbopogon Martini Oil, Michelia Alba Flower Oil, 1,2-Hexanediol, Polyglyceryl-2 Stearate, Glyceryl Stearate, Stearyl Alcohol, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-20 Alkyl Glucoside, Cetearyl Alcohol, Hydrogenated Olive Oil Unsaponifiables, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Maltodextrin, Cyanocobalamin, Sodium Citrate, Citric Acid, Tromethamine, Disodium EDTA

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: - Gently apply an appropriate amount to the skin. - Apply in daily skin care routine

Use

Use: helps prevent and relieve chapped or cracked skin

Active Ingredient (ACTIVE INGREDIENT)

Active ingredient: Niacinamide 2.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredient: Prunus Yedoensis Flower Extract, Methylpropanediol, Cyclomethicone, Hydrogenated Ethylhexyl Olivate, PPG-14 Butyl Ether, C14-22 Alcohols, Olea Europaea (Olive) Fruit Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Pelargonium Graveolens Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Cymbopogon Martini Oil, Michelia Alba Flower Oil, 1,2-Hexanediol, Polyglyceryl-2 Stearate, Glyceryl Stearate, Stearyl Alcohol, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-20 Alkyl Glucoside, Cetearyl Alcohol, Hydrogenated Olive Oil Unsaponifiables, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Maltodextrin, Cyanocobalamin, Sodium Citrate, Citric Acid, Tromethamine, Disodium EDTA

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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