CELLISYS EX WRINKLE SOLUTION- dimethicone cream

Cellisys EX Wrinkle Solution by

Drug Labeling and Warnings

Cellisys EX Wrinkle Solution by is a Otc medication manufactured, distributed, or labeled by DN Company Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Dimethicone 0.3%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Glycerin, Cyclopentasiloxane, Mineral Oil, Cetearyl Alcohol, Hydrogenated Poly(C6-14 Olefin), Petrolatum, PEG-40 Stearate, Sorbitan Stearate, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Trehalose, Phenoxyethanol, Methylparaben, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Fragrance(Parfum), Triethanolamine, Carbomer, Caprylic/Capric Triglyceride, Alcohol Denat., Propylparaben, Betaine, Macadamia Integrifolia Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ceramide NP, Sodium Polyacrylate, Tocopheryl Acetate, Xanthan Gum, Adenosine, Pseudoalteromonas Ferment Extract, Hydrogenated Lecithin, Disodium EDTA, Butylene Glycol, Argania Spinosa Kernel Oil, Phytosphingosine, BHT, Potassium Cetyl Phosphate, Sodium Hyaluronate, Thermus Thermophillus Ferment, Sodium Ascorbyl Phosphate, Polysorbate 20, Yellow 5 (CI 19140), sh-Oligopeptide-1, Yellow 6 (CI 15985), Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-5, Palmitoyl Tetrapeptide-7

PURPOSE

PURPOSE: Skin protectant, Anti wrinkle

WARNINGS

WARNING: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. Keep out of reach of babies and children.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

INDICATIONS AND USAGE

INDICATION AND USAGE: Apply an adequate amount onto the entire face and neck at the last step of skin care.

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION: Apply proper amount to the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CELLISYS EX WRINKLE SOLUTION 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-014-02	1 in 1 BOX	07/01/2013
1	NDC: 60565-014-01	50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2013

Labeler - DN Company Co., Ltd. (688369859)

Registrant - DN Company Co., Ltd. (688369859)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60565-014)