MELANO OUT CREAM- allantoin, glycerin 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.

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Melano Out Cream

Warnings

Stop use and ask a Doctor if rash occurs

WARNINGS

USES

DIRECTIONS

QUESTIONS OR COMMENTS ?

ACTIVE INGREDIENTS

Active Ingredients Purpose

Allantoin 0.01%................................Skin Protectant

Glycerin 0.25%.................................Skin Protectant

Inactive Ingredients

Water, Azelaic Acid, Mineral Oil, Ethylhexyl Methoxycinnamate, Cetearyl Alcohol, Salicylic Acid, Kojic Acid,,Arbutin, Phenoxyethanol, Glycyrrhetinic Acid, Citric Acid, Lactic Acid, Phytic Acid, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Ascorbic Acid, Sodium, Lactate, Serine, Sorbitol, Tea-lactate, Urea, Ethylhexylglycerin, Sodium Chloride

Box

Melano Out Cream

Melano Out Cream

Skin Protecting

Cream

MELANO OUT CREAM 
allantoin, glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70663-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) 1 mg  in 1 mL
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) 6 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 52.19 mg  in 1 mL
AZELAIC ACID (UNII: F2VW3D43YT) 15 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) 13 mg  in 1 mL
CETYL ALCOHOL (UNII: 936JST6JCN) 5.4 mg  in 1 mL
KOJIC ACID (UNII: 6K23F1TT52) 1 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.5 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT) 0.5 mg  in 1 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) 0.25 mg  in 1 mL
SORBITOL, L- (UNII: 01Q0586BG1) 0.25 mg  in 1 mL
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O) 0.25 mg  in 1 mL
ARBUTIN (UNII: C5INA23HXF) 0.9 mg  in 1 mL
ALLANTOIN GLYCYRRHETINIC ACID (UNII: H6FL381368) 0.6 mg  in 1 mL
FYTIC ACID (UNII: 7IGF0S7R8I) 0.5 mg  in 1 mL
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) 0.3 mg  in 1 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.3 mg  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) 0.25 mg  in 1 mL
SERINE (UNII: 452VLY9402) 0.25 mg  in 1 mL
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) 0.25 mg  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.05 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70663-007-0230 in 1 BOX12/17/2016
1NDC:70663-007-0130 mL in 1 CONTAINER; 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 SYSTEM S.A. (768263100)
Establishment
NameAddressID/FEIBusiness Operations
MESO SYSTEM S.A.768263100manufacture(70663-007)

Revised: 12/2016
Document Id: 43e51c3c-adc6-3f98-e054-00144ff88e88
Set id: 43e51c3c-adc5-3f98-e054-00144ff88e88
Version: 1
Effective Time: 20161217
 
MESO SYSTEM S.A.