Warnings

Stop use and ask a Doctor if rash occurs

WARNINGS

For external use only.
Do no use on damaged or broken skin
Stop use and ask a doctor if rash occurs
Avoid the product from entering your eyes
Children under 6 months Ask a Doctor

USES

Mask formulated to attenuate and eliminate coetanous spots of melanic origin located at epidemic levels.

Keep out of the reach of chuldren.
In case of overdose get medical help or Contact a Poison Control Center right away.

DIRECTIONS

Clean the skin thoroughly before applying the mask
Covered the entire skin with a thin layer
Single use

QUESTIONS OR COMMENTS ?

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

ACTIVE INGREDIENTS

Active Ingredients Purpose

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

Mineral Oil 2%................................Skin Protectant

Allantoin 2%...................................Skin Protectant

Inactive Ingredients

Water, Urea, Apricot Kernel Oil Peg-6 Esters, Isohexadecane, Lactic Acid, Azelaic Acid, Cetearyl Alcohol, Sodium Lactate, Arbutin, Propylene Glycol, Glycyrrhiza Glabra Root, Sodium Acrylate, Acryloyldimethyltaurate Copolymer, Polysorbate 80, Glycyrrhetinic Acid, Phytic Acid, Ascorbic Acid, Kojic Acid, Sodium Lauryl Sulfate, Sodium Cetearyl Sulfate, Serine, Tea-lactate, Sodium Chloride, Citric Acid, Phenoxyethanol, Salicylic Acid, Sorbitol, Ethylhexylglycerin

Box

Mask formulated to attenuate and eliminate coetanous spots of melanic origin located at epidemic levels.

MELANO OUT MASK CREAM

Cylinder

MELANO OUT MASK
glycerin, mineral oil, allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70663-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	8 mg in 1 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	2 mg in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)	0.1 mg in 1 mL
ISOHEXADECANE (UNII: 918X1OUF1E)	3 mg in 1 mL
WATER (UNII: 059QF0KO0R)	38.8 mg in 1 mL
LACTIC ACID (UNII: 33X04XA5AT)	3 mg in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.9 mg in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.1 mg in 1 mL
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)	3 mg in 1 mL
UREA HYDROCHLORIDE (UNII: RCE1061F6A)	8 mg in 1 mL
AZELAIC ACID (UNII: F2VW3D43YT)	2 mg in 1 mL
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)	2 mg in 1 mL
SODIUM LACTATE (UNII: TU7HW0W0QT)	2 mg in 1 mL
ARBUTIN (UNII: C5INA23HXF)	2 mg in 1 mL
PROPANEDIOL (UNII: 5965N8W85T)	2 mg in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)	2 mg in 1 mL
SODIUM ACRYLATE (UNII: 7C98FKB43H)	2 mg in 1 mL
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)	2 mg in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	2 mg in 1 mL
ENOXOLONE (UNII: P540XA09DR)	2 meq in 1 mL
FYTIC ACID (UNII: 7IGF0S7R8I)	2 mg in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R)	2 mg in 1 mL
KOJIC ACID (UNII: 6K23F1TT52)	1 mg in 1 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	1 mg in 1 mL
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)	1 mg in 1 mL
SERINE (UNII: 452VLY9402)	1 mg in 1 mL
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)	1 mg in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	1 mg in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	1 mg in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ)	0.1 mg in 1 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70663-010-02	15 in 1 BOX	12/18/2016
1	NDC:70663-010-01	15 mL in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/18/2016

Labeler - MESO SYSTEM S.A. (768263100)

Registrant - MESO SYSTEM S.A. (768263100)

Name	Address	ID/FEI	Business Operations
Establishment
MESO SYSTEM S.A.		768263100	manufacture(70663-010)