BY PHARMICELL LAB THE PRESTIGE ESSENCE- 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, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, GLYCERIN, DIPROPYLENE GLYCOL, HYDROGENATED POLYDECENE, NEOPENTYL GLYCOL DICAPRATE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, GLYCERYL STEARATE SE, HYDROGENATED LECITHIN, 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, HYDROGENATED LECITHIN, TOCOPHERYL ACETATE, CARBOMER, PHENOXYETHANOL, 1,2-HEXANEDIOL, XANTHAN GUM, POTASSIUM HYDROXIDE, LITHOSPERMUM ERYTHRORHIZON ROOT OIL, DIPOTASSIUM GLYCYRRHIZATE, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CLADOSIPHON OKAMURANUS EXTRACT, CERAMIDE 3, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, LECITHIN, ADENOSINE, SODIUM HYALURONATE, DEXTRIN, 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 pumping a proper amount of the essence, spread it evenly along the lines of the face for sufficient absorption.

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 THE PRESTIGE ESSENCE 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.22 mg  in 45 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60949-020-0145 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(60949-020)

Revised: 11/2013
Document Id: 87154bb0-de2b-4d33-8ad7-532b5963294d
Set id: 32375e2d-b943-4e7c-af44-4867df9ac0c1
Version: 1
Effective Time: 20131119
 
Pharmicell Co., Ltd.