Ammonium Lactate
Ammonium Lactate Cream, 12%*
Approved
Approval ID
7096d38e-2bd1-4374-9bf6-7fd09ef7509c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2021
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ammonium Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45802-493
Application NumberANDA075774
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ammonium Lactate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 6, 2017
FDA Product Classification
INGREDIENTS (13)
AMMONIUM LACTATEActive
Quantity: 12 g in 100 g
Code: 67M901L9NQ
Classification: ACTIM
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
LAURETH-4Inactive
Code: 6HQ855798J
Classification: IACT