SPL v1
SPL
SPL Set ID 695d4b6b-9f5a-46a8-8134-c4b5f69eeb22
Route
TOPICAL
Published
Effective Date 2016-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (2.8 g)
Inactive Ingredients
Water Glycereth-26

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-04-02

Description

Active Ingredient: NIACINAMIDE 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: NIACINAMIDE 2.0%

Warnings

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product. Keep out of reach of children

Active Ingredient

Active Ingredient: NIACINAMIDE 2.0%

Inactive Ingredient

Inactive Ingredients: WATER, GLYCERETH-26,BUTYLENE GLYCOL,NIACINAMIDE,HYDROXYL UREA,POLYSORBATE 80,CARBOMER,ARGININE,PEG-60 HYDROGENATED CASOR OIL,1,2-HEXANEDIOL,PORTULACA OLERACEA EXTRACT, CAPRYLHYDROX AMICACID,GLYCERIN,BETAINE,SYNTHETIC FLUORPHLOGOPITE,TITANIUM DIOXIDE,PERFUME,SALVIA HISPANICA SEED EXTRACT,ALLANTOIN,OCIMUM BASILICUM(BASIL)FLOWER/LEAF/STEM EXTRACT,AVENA SATIVA(OAT)KERNEL EXTRACT, CAULERPA LENTILLIFERA EXTRACT,ADENOSINE,CANNABIS SATIVA SEED OIL(560ppm),BUTYROSPERMUM PARKII(SHEA BUTTER),SODIUMHYALURONATE,PHENOXYETHANOL,HYDRO GENATED LECITHIN,CAPRYLYL GLYCOL,CYCLOPENTASILOXANE,IRONOXIDE,LECITHIN,SODIU M POLYACRYLATE,MENTHA PIPERITA(PEPPERMINT)LEAF WXTRACT,CHAMOMILLA RECUTITA(MATRICARIA)LEAF EXTRACT,MENTHAROTUNDIFOLIA LEAF EXTRACT,SALVIA OFFICINALIS(SAGE)LEAF EXTRACT,ROSACENTIFOLIA FLOWER EXTRACT,MONARDA DIDYMA LEAF EXTRACT,ROSM ARINUS OFFICINALIS(ROSEMARY)LEAF EXTRACT,MELISSA OFFICINALIS LEAF EXTRACT,LAVADULA ANGUSTIFOLIA(LAVENDER)FLOWER EXTRACT,BETAGLUCAN, TROPOLONE,DISODIUMEDTA,TIN OXIDE

Indications & Usage

Indications & usage: Apply smoothly on the entire face in the morning and night.

Dosage & Administration

Dosage & Administration: Take an adequate amount of this product.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product. Keep out of reach of children

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: NIACINAMIDE 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: WATER, GLYCERETH-26,BUTYLENE GLYCOL,NIACINAMIDE,HYDROXYL UREA,POLYSORBATE 80,CARBOMER,ARGININE,PEG-60 HYDROGENATED CASOR OIL,1,2-HEXANEDIOL,PORTULACA OLERACEA EXTRACT, CAPRYLHYDROX AMICACID,GLYCERIN,BETAINE,SYNTHETIC FLUORPHLOGOPITE,TITANIUM DIOXIDE,PERFUME,SALVIA HISPANICA SEED EXTRACT,ALLANTOIN,OCIMUM BASILICUM(BASIL)FLOWER/LEAF/STEM EXTRACT,AVENA SATIVA(OAT)KERNEL EXTRACT, CAULERPA LENTILLIFERA EXTRACT,ADENOSINE,CANNABIS SATIVA SEED OIL(560ppm),BUTYROSPERMUM PARKII(SHEA BUTTER),SODIUMHYALURONATE,PHENOXYETHANOL,HYDRO GENATED LECITHIN,CAPRYLYL GLYCOL,CYCLOPENTASILOXANE,IRONOXIDE,LECITHIN,SODIU M POLYACRYLATE,MENTHA PIPERITA(PEPPERMINT)LEAF WXTRACT,CHAMOMILLA RECUTITA(MATRICARIA)LEAF EXTRACT,MENTHAROTUNDIFOLIA LEAF EXTRACT,SALVIA OFFICINALIS(SAGE)LEAF EXTRACT,ROSACENTIFOLIA FLOWER EXTRACT,MONARDA DIDYMA LEAF EXTRACT,ROSM ARINUS OFFICINALIS(ROSEMARY)LEAF EXTRACT,MELISSA OFFICINALIS LEAF EXTRACT,LAVADULA ANGUSTIFOLIA(LAVENDER)FLOWER EXTRACT,BETAGLUCAN, TROPOLONE,DISODIUMEDTA,TIN OXIDE

Indications & Usage (INDICATIONS & USAGE)

Indications & usage: Apply smoothly on the entire face in the morning and night.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage & Administration: Take an adequate amount of this product.

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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