BY PHARMICELL LAB THE PRESTIGE- glycerin 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 : GLYCERIN 20%

INACTIVE INGREDIENT

Inactive ingredients : WATER, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, BUTYLENE GLYCOL, CETYL ETHYLHEXANOATE, HYDROGENATED POLYDECENE, CETEARYL ALCOHOL, NIACINAMIDE, HYDROGENATED VEGETABLE OIL, VEGETABLE OIL, BUTYROSPERMUM PARKII(SHEA BUTTER), DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, STEARIC ACID, CETEARETH-20, DIMETHICONE, GLYCERYL STEARATE, MACADAMIA TERNIFOLIA SEED OIL, CETYL PEG/PPG-10/1 DIMETHICONE, 1,2-HEXANEDIOL, PHENOXYETHANOL, HYDROGENATED LECITHIN, XANTHAN GUM, SODIUM POLYACRYLATE, PANAX GINSENG ROOT EXTRACT, CLADOSIPHON OKAMURANUS EXTRACT, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CERAMIDE 3, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, LECITHIN, DEXTRIN, POLYACRYLATE-13, POLYISOBUTENE, POLYSORBATE 20, ADENOSINE, CITRUS MEDICA LIMONUM (LEMON) FRUIT OIL, JASMINUM OFFICINALE (JASMINE) OIL, ROSA CENTIFOLIA FLOWER OIL, 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 : After taking the cream with a size of pea using a spatula, spread it evenly over the face and neck, and massage gently 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 THE PRESTIGE 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60949-010-0150 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(60949-010)

Revised: 7/2013
Document Id: 0b59bb23-7535-402c-a5c2-f6d47158dc74
Set id: 012843a1-df10-4622-ab13-5b9260dc8c0e
Version: 1
Effective Time: 20130702
 
Pharmicell Co., Ltd.