0.025% Capsaicin Patch
Approved
Approval ID
1ac7526d-c253-66d3-e063-6294a90a42d1
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Dec 30, 2024
Manufacturers
FDA
Koolcare Technology Co., Ltd.
DUNS: 602479389
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pain relief patch, pain relief strip
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84205-003
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pain relief patch, pain relief strip
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 30, 2024
FDA Product Classification
INGREDIENTS (15)
LIDOCAINEActive
Quantity: 0.04 g in 1 g
Code: 98PI200987
Classification: ACTIB
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOL, (+)-Active
Quantity: 0.01 g in 1 g
Code: C6B1OE8P3W
Classification: ACTIM
Capsaicin Pain relief patch, Capsaicin pain relief strip
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84205-001
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Capsaicin Pain relief patch, Capsaicin pain relief strip
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 30, 2024
FDA Product Classification
INGREDIENTS (13)
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
CAPSAICINActive
Quantity: 0.25 mg in 1 g
Code: S07O44R1ZM
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Lidocaine Pain relief patch
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84205-002
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine Pain relief patch
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 30, 2024
FDA Product Classification
INGREDIENTS (13)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
LIDOCAINEActive
Quantity: 0.04 g in 1 g
Code: 98PI200987
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Pain relief patch
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84205-004
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pain relief patch
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 30, 2024
FDA Product Classification
INGREDIENTS (13)
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
MENTHOL, (+)-Active
Quantity: 0.05 g in 1 g
Code: C6B1OE8P3W
Classification: ACTIB