SPL v1
SPL
SPL Set ID 575fbe21-edff-40e5-9a56-660f6b0e0a8c
Route
TOPICAL
Published
Effective Date 2018-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (1.0 g) Adenosine (0.02 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-08-01

Description

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Purpose

Purpose: Skin Brightening & Anti wrinkle


Medication Information

Purpose

Purpose: Skin Brightening & Anti wrinkle

Description

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Warnings

Warnings: 1. Discontinue use immediately and consult a dermatologist, if you experience the following: 1) Irritation, Red spots, itchy skin or rash 2) Applied skin area has the above reaction from direct sun 2. Do not use on irritated skin, cuts, or other infected skin area. 3. Avoid contact with eyes. 4. close the cap after using. 5. keep out of reach of children.

Active Ingredient

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Inactive Ingredient

Inactive ingredients: WATER,GLYCERIN,BUTYLENE GLYCOL,BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE,LIMNANTHES ALBA (MEADOWFOAM) SEED OIL,SQUALANE,HYDROGENATED VEGETABLE OIL,BUTYROSPERMUM PARKII (SHEA BUTTER),BEHENYL ALCOHOL,CETEARYL ALCOHOL,GLYCERYL STEARATE,POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE,PENTYLENE GLYCOL,HYDROGENATED LECITHIN,DIMETHICONE,STEARYL ALCOHOL,PEG-100 STEARATE,BEHENIC ACID,CARBOMER,TROMETHAMINE,PHENOXYETHANOL,CAPRYLYL GLYCOL,STEARIC ACID,XANTHAN GUM,MADECASSOSIDE,POLYPERFLUOROMETHYLISOPROPYL ETHER,MYRISTIC ACID,DISODIUM EDTA,ALTEROMONAS FERMENT EXTRACT,PROPYLENE GLYCOL,POLOXAMER 188,POLYPERFLUOROETHOXYMETHOXY DIFLUOROETHYL PEG PHOSPHATE,POTASSIUM CETYL PHOSPHATE,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES,GLYCERYL CAPRYLATE,MACADAMIA TERNIFOLIA SEED OIL,CERAMIDE 3,PHYTOSPHINGOSINE,MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

Indications & Usage

Indications & Usage: Suggested use is 1-2 times a day

Dosage & Administration

Dosage & Administration: 1. use morning and evening after regular skin care routine. 2. Apply evenly to the affected area. 3. smooth gently until completely absorbed.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Brightening & Anti wrinkle

Warnings (WARNINGS)

Warnings: 1. Discontinue use immediately and consult a dermatologist, if you experience the following: 1) Irritation, Red spots, itchy skin or rash 2) Applied skin area has the above reaction from direct sun 2. Do not use on irritated skin, cuts, or other infected skin area. 3. Avoid contact with eyes. 4. close the cap after using. 5. keep out of reach of children.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: WATER,GLYCERIN,BUTYLENE GLYCOL,BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE,LIMNANTHES ALBA (MEADOWFOAM) SEED OIL,SQUALANE,HYDROGENATED VEGETABLE OIL,BUTYROSPERMUM PARKII (SHEA BUTTER),BEHENYL ALCOHOL,CETEARYL ALCOHOL,GLYCERYL STEARATE,POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE,PENTYLENE GLYCOL,HYDROGENATED LECITHIN,DIMETHICONE,STEARYL ALCOHOL,PEG-100 STEARATE,BEHENIC ACID,CARBOMER,TROMETHAMINE,PHENOXYETHANOL,CAPRYLYL GLYCOL,STEARIC ACID,XANTHAN GUM,MADECASSOSIDE,POLYPERFLUOROMETHYLISOPROPYL ETHER,MYRISTIC ACID,DISODIUM EDTA,ALTEROMONAS FERMENT EXTRACT,PROPYLENE GLYCOL,POLOXAMER 188,POLYPERFLUOROETHOXYMETHOXY DIFLUOROETHYL PEG PHOSPHATE,POTASSIUM CETYL PHOSPHATE,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES,GLYCERYL CAPRYLATE,MACADAMIA TERNIFOLIA SEED OIL,CERAMIDE 3,PHYTOSPHINGOSINE,MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

Indications & Usage (INDICATIONS & USAGE)

Indications & Usage: Suggested use is 1-2 times a day

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage & Administration: 1. use morning and evening after regular skin care routine. 2. Apply evenly to the affected area. 3. smooth gently until completely absorbed.

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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