NDC 70663-007

Melano Out Cream

Allantoin, Glycerin

Melano Out Cream is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Meso System S.a.. The primary component is Allantoin; Glycerin.

Product ID70663-007_43e51c3c-adc6-3f98-e054-00144ff88e88
NDC70663-007
Product TypeHuman Otc Drug
Proprietary NameMelano Out Cream
Generic NameAllantoin, Glycerin
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-12-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameMESO SYSTEM S.A.
Substance NameALLANTOIN; GLYCERIN
Active Ingredient Strength0 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70663-007-02

30 CONTAINER in 1 BOX (70663-007-02) > 30 mL in 1 CONTAINER (70663-007-01)
Marketing Start Date2016-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70663-007-02 [70663000702]

Melano Out Cream CREAM
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-12-17
Inactivation Date2020-01-31

NDC 70663-007-01 [70663000701]

Melano Out Cream CREAM
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-12-17

Drug Details

Active Ingredients

IngredientStrength
ALLANTOIN.1 mg/mL

OpenFDA Data

SPL SET ID:43e51c3c-adc5-3f98-e054-00144ff88e88
Manufacturer
UNII
UPC Code
  • 8437008109428
  • NDC Crossover Matching brand name "Melano Out Cream" or generic name "Allantoin, Glycerin"

    NDCBrand NameGeneric Name
    70663-007Melano Out CreamAllantoin, Glycerin
    69318-001AN12Allantoin, Glycerin
    81459-303repuera DermAtozyme 5% Hydro Essential AmpuleAllantoin, GLYCERIN
    69405-001Seniorclean BioAllantoin, Glycerin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.