BY PHARMICELL LAB LUXURY CELL PERFORMANCE TONER- 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.

----------

ACTIVE INGREDIENT

Active ingredient : ALLANTOIN 0.5%

INACTIVE INGREDIENT

Inactive ingredient : WATER, GLYCERIN, ALCOHOL, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, DIPROPYLENE GLYCOL, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, BETAINE, TREHALOSE, METHYL GLUCETH-20, POLYGONUM MULTIFLORUM ROOT EXTRACT, ACANTHOPANAX SENTICOSUS (ELEUTHERO) ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PANAX GINSENG ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, 1,2-HEXANEDIOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PHENOXYETHANOL, XANTHAN GUM, 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, PEG-40 HYDROGENATED CASTOR OIL, POTASSIUM HYDROXIDE, ADENOSINE, SODIUM HYALURONATE, 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 wash up, take a proper amount of toner, and spread it evenly over the entire face using a cotton pad for 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 LUXURY CELL PERFORMANCE TONER 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-090
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60949-090-01130 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(60949-090)

Revised: 7/2013
Document Id: f09e4bf2-1147-4c1d-8e3d-06dee3541ee7
Set id: b818a187-1954-43d7-ad48-8e0fad8c61d1
Version: 1
Effective Time: 20130708
 
Pharmicell Co., Ltd.