HYDRAFACE- glycerin, dimethicone cream

Hydraface by

Drug Labeling and Warnings

Hydraface by is a Otc medication manufactured, distributed, or labeled by MESO SYSTEM S A, Meso Systems S A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Warnings

• For external use only
• Do not use on damaged or broken sin

Stop use and ask a Doctor if

• Rash occurs
• When using this products keep out of eyes. Rinse with water to remove
• Children under 6 months: ask a doctor

WARNINGS

For external use only.

• When using this product do not get into eyes. Rinse with water to remove

Stop use and ask a Doctor if

• Rash occurs

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 CHILDREN

Keep out of reach of babies and childrens

DIRECTIONS

• Clean and tonify te face and the neck
• Apply every day gently onto clean face and neck
• Can be used in the morning and/or night.

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

PRINCIPAL DISPLAY PANEL

HYDRAFACE CREAM

Skin Protectant

INGREDIENTS AND APPEARANCE

HYDRAFACE 
glycerin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70663-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70663-009-02	50 in 1 CARTON	12/17/2016
1	NDC: 70663-009-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/17/2016

Labeler - MESO SYSTEM S A (768263100)

Registrant - Meso Systems S A (768263100)

Establishment
Name	Address	ID/FEI	Business Operations
Meso Systems S A		768263100	manufacture(70663-009)