MELANO OUT MASK- glycerin, mineral oil, allantoin cream

Melano Out Mask by

Drug Labeling and Warnings

Melano Out Mask by is a Otc medication manufactured, distributed, or labeled by MESO SYSTEM S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 REACH OF CHILDREN

• 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

INDICATIONS & USAGE

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

MELANO OUT MASK CREAM

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/18/2016

Labeler - MESO SYSTEM S.A. (768263100)

Registrant - MESO SYSTEM S.A. (768263100)

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