SPL v1
SPL
SPL Set ID 608946b6-1770-4964-8248-f1a7288ed194
Route
TOPICAL
Published
Effective Date 2016-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (0.6 g)
Inactive Ingredients
Water Shea Butter

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-12-01

Description

Active ingredients: Niacinamide 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredients: 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 routined

Active Ingredient

Active ingredients: Niacinamide 2.0%

Inactive Ingredient

Inactive ingredients: Water, Butyrospermum Parkii (Shea) Butter, Glycerin, Cetyl Ethylhexanoate, Cetearyl Alcohol, Butylene Glycol, Glyceryl Stearate, Polysorbate 60, PEG/PPG-17/6 Copolymer, Cyclopentasiloxane, Hydrogenated Polydecene, Beeswax, Cyclohexasiloxane, Palmitic Acid, Stearic Acid, Xanthan Gum, Dimethicone, PEG-100 Stearate, Fragrance, Phenoxyethan ol, Tocopheryl Acetate, Polyacrylate-13, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Sorbitan Stearate, Caprylyl Glycol, Honey Extract, Phyllostachis Bambusoides Juice, Sorbitan Isostearate, Polysorbate 20, Disodium EDTA, Alcohol, Polyglutamic Acid, Citric Acid

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 routined

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Butyrospermum Parkii (Shea) Butter, Glycerin, Cetyl Ethylhexanoate, Cetearyl Alcohol, Butylene Glycol, Glyceryl Stearate, Polysorbate 60, PEG/PPG-17/6 Copolymer, Cyclopentasiloxane, Hydrogenated Polydecene, Beeswax, Cyclohexasiloxane, Palmitic Acid, Stearic Acid, Xanthan Gum, Dimethicone, PEG-100 Stearate, Fragrance, Phenoxyethan ol, Tocopheryl Acetate, Polyacrylate-13, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Sorbitan Stearate, Caprylyl Glycol, Honey Extract, Phyllostachis Bambusoides Juice, Sorbitan Isostearate, Polysorbate 20, Disodium EDTA, Alcohol, Polyglutamic Acid, Citric Acid

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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