Label: MELANO OUT MASK- glycerin, mineral oil, allantoin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70663-010-01, 70663-010-02 - Packager: MESO SYSTEM S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 18, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Warnings
- WARNINGS
- USES
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- QUESTIONS OR COMMENTS ?
- ACTIVE INGREDIENTS
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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
- MELANO OUT MASK CREAM
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INGREDIENTS AND APPEARANCE
MELANO OUT MASK
glycerin, mineral oil, allantoin creamProduct 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)
