MELANO OUT CREAM- allantoin, glycerin cream

Melano Out Cream by

Drug Labeling and Warnings

Melano Out Cream 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

• Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level

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 cream.
• Cover the entire affected area with a thin layer. First week apply three times daily (morning-afternoon-night). Second week apply two times daily (morning-night). Third week apply once a day for one year.
• During summer it is recommended the application of the cream after sun exposure. If bothersome dryness or peeling occurs, reduce application to once a day or every other day

QUESTIONS OR COMMENTS ?

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

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

INDICATIONS & USAGE

• Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level

Melano Out Cream

Melano Out Cream

Skin Protecting

INGREDIENTS AND APPEARANCE

MELANO OUT CREAM 
allantoin, glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70663-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.1 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70663-007-02	30 in 1 BOX	12/17/2016
1	NDC: 70663-007-01	30 mL in 1 CONTAINER; 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 SYSTEM S.A. (768263100)

Establishment
Name	Address	ID/FEI	Business Operations
MESO SYSTEM S.A.		768263100	manufacture(70663-007)