SPL v1
SPL
SPL Set ID 20a4273e-0258-47b6-be4a-70b1713a9c2f
Route
TOPICAL
Published
Effective Date 2016-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (3.0 g) Niacinamide (1.0 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-05-01

Description

Active ingredient: Glycerin 6.0%, Niacinamide 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredient: Glycerin 6.0%, 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 6.0%, Niacinamide 2.0%

Inactive Ingredient

Inactive Ingredient: Water, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Titanium Dioxide (CI 77891), Alcohol Denat., Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Phenoxyethanol, Chlorphenesin, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Fragrance, Caprylyl Glycol, Honey Extract, Phyllostachis Bambusoides Juice, Disodium EDTA, Alcohol

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 6.0%, Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredient: Water, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Titanium Dioxide (CI 77891), Alcohol Denat., Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Phenoxyethanol, Chlorphenesin, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Fragrance, Caprylyl Glycol, Honey Extract, Phyllostachis Bambusoides Juice, Disodium EDTA, Alcohol

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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