Capsaicin 0.05% Cream
Capsaicin 0.05% Cream
Approved
Approval ID
2cf17a28-711f-77bd-e063-6394a90a7061
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 28, 2025
Manufacturers
FDA
Puretek Corporation
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Capsaicin 0.05%
PRODUCT DETAILS
NDC Product Code59088-223
Application NumberM017
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateFebruary 28, 2025
Generic NameCapsaicin 0.05%
INGREDIENTS (32)
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
GINGERInactive
Code: C5529G5JPQ
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
MYRISTYL MYRISTATEInactive
Code: 4042ZC00DY
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMESInactive
Code: 9S60Q72309
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CAPSICUM OLEORESINActive
Quantity: 0.5 mg in 1 g
Code: UW86K581WY
Classification: ACTIR
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
AQUAInactive
Code: 059QF0KO0R
Classification: IACT
GINKGO BILOBA LEAFInactive
Code: 19FUJ2C58T
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILInactive
Code: ZBP1YXW0H8
Classification: IACT
LAURETH-7Inactive
Code: Z95S6G8201
Classification: IACT
C13-14 ISOPARAFFINInactive
Code: E4F12ROE70
Classification: IACT
CALCIUM PANTOTHENATEInactive
Code: 568ET80C3D
Classification: IACT
PYRIDOXINE HCLInactive
Code: 68Y4CF58BV
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
SODIUM ASCORBYL PHOSPHATEInactive
Code: 836SJG51DR
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%)Inactive
Code: 5F4963KLHS
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT