OTC Medication Information: INCELLDERM ACTIVE

INCELLDERM ACTIVE- niacinamide and adenosine cream
Riman Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

Active ingredients: Niacinamide 1.5%, Adenosine 0.04%

INACTIVE INGREDIENT

Inactive ingredients:


Centella Asiatica Leaf Water, Water, Centella Asiatica Leaf Water, Citrus Aurantlfolia (Lime) Fruit Extract, Caprylic/Capric Triglyceride, Macadamia Integrifolia Seed Oil, Butylene Glycol Dicaprylate/Dicaprate, Camellia Japonica Flower Extract, Rosmarinus Officinalis (Rosemary) Extract, Calendula Officinalis Extract, Chamomilla Recutita (Matricaria) Extract, Geranium Maculatum Extract
Glycerin, Butylene Glycol, Camellia Japonica Seed Oil, Argania Spinosa Kernel Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Polyglyceryl-4 Caprate, Propanediol, Heptyl Undecylenate, Polyglyceryl-2 Stearate, Glyceryl Stearate, Stearyl Alcohol, Sodium Polyacryloyldimethyl Taurate, Hydrogenated Polydecene, Trideceth-10, 1,2-Hexanediol, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schizandra Chinensis Fruit Extract, Coptis Chinensis Root Extract, Camellia Sinensis Leaf Extract, Propolis Wax, Caprylyl glycol, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Carthamus Tinctorius (Safflower) Oleosomes, Hydroxydecyl Ubiquinone, Panthenol, Hydrogenated Lecithin, Glycine Soja(Soybean) Sterols, Sodium Hyaluronate, Ethylhexylglycerin, Carbomer, Tromethamine, Sparassis Crispa Extract, Disodium EDTA, Octyldodecanol, Ceramide NP, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Solanum Lycopersicum (Tomato) Callus Culture Extract, Oryza Sativa (Rice) Callus Culture Extract, Ipomoea Hederacea Callus Culture Extract, Panax Ginseng Callus Culture Extract, Nelumbo Nucifera Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Nicotinoyl Tripeptide-1, rh-Oligopeptide-1, Palmitoyl Pentapeptide-4, Alcohol, Acetyl Hexapeptide-8, Hexapeptide-42, Copper Tripeptide-1, Glycine Soja (Soybean) Germ Extract, Madecassoside, Mineral Water, Salix Alba (Willow) Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Cinnamomum cassia bark Extract, Scutellaria Baicalensis Root Extract, Portulaca Oleracea Extract, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Laminaria Digitata Extract, Undaria Pinnatifida Extract, Snail Secretion Filtrate, Larix Sibirica Wood Extract, Chrysanthellum Indicum Extract, Rheum Palmatum Root/Stalk Extract, Asarum Sieboldi Root Extract, Quercus Mongolia Leaf Extract, Persicaria Hydropiper Extract, Illicium Verum (Anise) Fruit Extract, Corydalis Turtschaninovii Root Extract, Coptis Japonica Root Extract, Machilus Thunbergii Bark Extract, Palmitoyl Tripeptide-5

PURPOSE

Purpose: Skin Brightening, Anti-wrinkle

WARNINGS

Warnings:


1. Consult a physician if red spots, swollenness, itchiness, or any other adnormal symptoms or side effects develops on the applied area during or after use or under direct sunlight.
2. Do not use on wound, etc.
3. Precautions for handling and storage
a) Keep out of the reach of children
b) Avoid direct sunlight

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:
Helps to brighten the skin.
Helps to improve wrinkles in the skin.

Directions

Directions:
Take an appropriate amount and spread it evenly over the skin.
Please put the appropriate amount on the skin and wait (daub).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 1

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 2

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INCELLDERM ACTIVE
niacinamide, adenosine cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72650-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Niacinamide (NIACINAMIDE) Niacinamide 0.75 g in 50 mL
Adenosine (ADENOSINE) Adenosine 0.02 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
CENTELLA ASIATICA LEAF
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72650-010-02 1 CONTAINER in 1 CARTON contains a CONTAINER (72650-010-01)
1 NDC:72650-010-01 50 mL in 1 CONTAINER This package is contained within the CARTON (72650-010-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2019
Labeler — Riman Co., Ltd. (694893735)
Registrant — Riman Co., Ltd. (694893735)
Establishment
Name Address ID/FEI Operations
HANSOLBIOTECH 694455165 manufacture (72650-010)

Revised: 04/2019 Riman Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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