BY PHARMICELL LAB LUXURY CELL PERFORMANCE EMULSION- allantoin 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.

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ACTIVE INGREDIENT

Active ingredient : ALLANTOIN 0.5%

INACTIVE INGREDIENT

Inactive ingredient : WATER, HYDROGENATED POLYDECENE, BUTYLENE GLYCOL, GLYCERIN, TRIETHYLHEXANOIN, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, BEHENYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, BEHENIC ACID, ISOSTEARIC ACID, STEARIC ACID, HYDROGENATED LECITHIN, 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, PEG-5 GLYCERYL STEARATE, GLYCERYL STEARATE SE, POTASSIUM HYDROXIDE, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, GRIFOLA FRONDOSA EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, SPARASSIS CRISPA EXTRACT, PHELLINUS LINTEUS EXTRACT , CERAMIDE 3, ADENOSINE, 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

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 : After using the serum, apply the emulsion to the entire face evenly along the skin texture like massaging the entire face.

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BY PHARMICELL LAB LUXURY CELL PERFORMANCE EMULSION 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.65 mg  in 130 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60949-060-01130 mL 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(60949-060)

Revised: 7/2013
Document Id: a51869fd-48b9-405a-ba25-f1328ca35372
Set id: 554d5e2a-a73b-4291-9726-6adf6d265aa9
Version: 1
Effective Time: 20130707
 
Pharmicell Co., Ltd.