HYDRAFACE- glycerin, dimethicone cream 
MESO SYSTEM S A

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.

----------

HYDRAFACE CREAM

INACTIVE INGREDIENT

Water,Stearyl Alcohol, Steareth-2, Isopropyl Myristate, Sodium Lactate, Serine, Imidazolidinyl Urea. Phenoxyethanol.. Tea-Lactate

Tocopheryl Acetate.Lactic Acid. Ethylhexyl Methoxycinnamate.. Mimosa Tenuiflora Extract, Decyl Oleate, Steareth-21, Sorbitol, Glyceryl Linoleate, Glyceryl Linolenate,Glyceryl Arachidonate,BHT, Ethylhexylglycerin, Retinyl Palmitate, Butylphenyl Methylpropional, D-limonene, Linalool, Parfum

Box

Warnings

Stop use and ask a Doctor if

WARNINGS

For external use only.

Stop use and ask a Doctor if

USES

Hydrates deeple, offering elasticity, firmess and smoothness of the skin. Suitable for all kinds of dehyrated and devitalized skins. It helps to restore the optimun level of hydration and combats the free radicals prventing aging.

USES

Hydrates deeple, offering elasticity, firmess and smoothness of the skin. Suitable for all kinds of dehyrated and devitalized skins. It helps to restore the optimun level of hydration and combats the free radicals prventing aging.

Keep out of reach of babies and childrens

DIRECTIONS

QUESTIONS OR COMMENTS?

+35 1227347125 M-F: 9:00 am to 5:00 pm

ACTIVE INGREDIENT

ACTIVE INGREDIENT PURPOSE

Dimethicone 0.1%..........................................Skin Protectant

Glycerin 2%....................................................Skin Protectant

HYDRAFACE CREAM

Skin Protectant

Bottle

HYDRAFACE 
glycerin, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70663-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL LINOLENATE (UNII: SGB6X4G86K) 0.1 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
DECYL OLEATE (UNII: ZGR06DO97T) 0.1 mg  in 1 mL
STEARETH-21 (UNII: 53J3F32P58) 0.1 mg  in 1 mL
SORBITOL (UNII: 506T60A25R) 0.1 mg  in 1 mL
STEARETH-2 (UNII: V56DFE46J5) 4 mg  in 1 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 4 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 76.65 mg  in 1 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 4 mg  in 1 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) 2 mg  in 1 mL
SERINE (UNII: 452VLY9402) 2 mg  in 1 mL
IMIDUREA (UNII: M629807ATL) 2 mg  in 1 mL
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O) 0.5 mg  in 1 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.3 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT) 0.1 mg  in 1 mL
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) 0.1 mg  in 1 mL
MIMOSA TENUIFLORA LEAF (UNII: 46VJM10Q45) 0.1 mg  in 1 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.1 mg  in 1 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.1 mg  in 1 mL
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.1 mg  in 1 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.1 mg  in 1 mL
LINALOOL, (+)- (UNII: F4VNO44C09) 0.1 mg  in 1 mL
PEG-30 GLYCERYL LINOLEATE (UNII: UPJ8VI2ZOC) 0.1 mg  in 1 mL
GLYCERYL ARACHIDONATE (UNII: I4WS2B978B) 0.1 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N) 0.05 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70663-009-0250 in 1 CARTON12/17/2016
1NDC:70663-009-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/17/2016
Labeler - MESO SYSTEM S A (768263100)
Registrant - Meso Systems S A (768263100)
Establishment
NameAddressID/FEIBusiness Operations
Meso Systems S A768263100manufacture(70663-009)

Revised: 12/2016
Document Id: 43e5ce0a-bfaf-7207-e054-00144ff88e88
Set id: 43e5ce0a-bfae-7207-e054-00144ff88e88
Version: 1
Effective Time: 20161217
 
MESO SYSTEM S A