Crotan
CROTAN LOTION
Approved
Approval ID
6f7478fa-ed2b-4943-9d40-1fd0161a0854
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2023
Manufacturers
FDA
Marnel Pharmaceuticals, Inc.
DUNS: 080161449
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Crotamiton
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0682-0051
Application NumberANDA087204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Crotamiton
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (12)
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMER HOMOPOLYMER TYPE AInactive
Code: F68VH75CJC
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROTAMITONActive
Quantity: 100 mg in 1 g
Code: D6S4O4XD0H
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT