BY PHARMICELL LAB LUXURY CELL PERFORMANCE- dimethicone cream 
Pharmicell Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ACTIVE INGREDIENT

Active ingredient : DIMETHICONE 1%

INACTIVE INGREDIENT

Inactive ingredient : WATER, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, DIPROPYLENE GLYCOL, BUTYLENE GLYCOL, GLYCERIN, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, CETEARYL ALCOHOL, NEOPENTYL GLYCOL DICAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ETHYLHEXANOATE, BETAINE, BUTYROSPERMUM PARKII(SHEA BUTTER), STEARIC ACID, GLYCERYL STEARATE SE, PEG-40 STEARATE, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, BEESWAX, POLYGONUM MULTIFLORUM ROOT EXTRACT, ACANTHOPANAX SENTICOSUS (ELEUTHERO) ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PANAX GINSENG ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, 1,2-HEXANEDIOL, CARBOMER, PHENOXYETHANOL, CETEARETH-20, HYDROGENATED LECITHIN, GLYCERYL STEARATE, SORBITAN STEARATE, XANTHAN GUM, POTASSIUM HYDROXIDE, DIPOTASSIUM GLYCYRRHIZATE, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, GRIFOLA FRONDOSA EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, SPARASSIS CRISPA EXTRACT, PHELLINUS LINTEUS EXTRACT, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, POLYACRYLATE-13, POLYISOBUTENE, POLYSORBATE 20, CERAMIDE 3, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTUS GLOBULUS LEAF OIL, GERANIUM MACULATUM OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, MENTHA PIPERITA (PEPPERMINT)OIL, ADENOSINE, SODIUM HYALURONATE

PURPOSE

Purpose : Skin Protectant

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and babies.

INDICATIONS AND USAGE

Indications and usage : At the last step of skin care, take the cream with a size of pea using a spatula, and spread it evenly over the face and neck, and press the face lightly with both hands.

DOSAGE AND ADMINISTRATION

Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BY PHARMICELL LAB LUXURY CELL PERFORMANCE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60949-050-0150 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2013
Labeler - Pharmicell Co., Ltd. (687744110)
Registrant - Pharmicell Co., Ltd. (687744110)
Establishment
NameAddressID/FEIBusiness Operations
Pharmicell Co., Ltd.687744110manufacture(60949-050)

Revised: 7/2013
Document Id: 8b3e5f45-ff20-4884-a829-ca03f1332034
Set id: 163049fd-b6ff-4507-858b-90e881b85dbd
Version: 1
Effective Time: 20130707
 
Pharmicell Co., Ltd.