BY PHARMICELL LAB MOISTURIZING FACE TONING MIST- allantoin spray 
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(GLACIER WATER), WATER, BUTYLENE GLYCOL, GLYCERIN, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, 1,2-HEXANEDIOL, PHENOXYETHANOL, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, GRIFOLA FRONDOSA EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, SPARASSIS CRISPA EXTRACT, PHELLINUS LINTEUS EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, ACANTHOPANAX SENTICOSUS (ELEUTHERO) ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PANAX GINSENG ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, 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, TRISODIUM EDTA

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 : Before and after makeup, spray the mist frequently 10~20 cm away from the face in a dry indoor condition. This product can be used as an alternative to the toner, and shaking the product before use is not necessary as it has a compressed injection form.

DOSAGE AND ADMINISTRATION

Dosage and administration : Before and after makeup, spray the mist frequently 10~20 cm away from the face in a dry indoor condition.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BY PHARMICELL LAB MOISTURIZING FACE TONING MIST 
allantoin spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.6 mg  in 120 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60949-100-01120 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(60949-100)

Revised: 7/2013
Document Id: 1c8c2dfa-376c-4a14-b4ef-6744402a7033
Set id: c6b88f89-483c-4c6b-b03a-7c5258901799
Version: 1
Effective Time: 20130708
 
Pharmicell Co., Ltd.