Medrox-Rx
Medrox-Rx
Approved
Approval ID
d9475b6c-edd1-4ea7-a22c-243e63c4d0f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2011
Manufacturers
FDA
Pharmaceutica North America, Inc.
DUNS: 962739699
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methyl salicylate, menthol, capsaicin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45861-005
Application Numberpart348
Product Classification
M
Marketing Category
C73603
G
Generic Name
methyl salicylate, menthol, capsaicin
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 27, 2011
FDA Product Classification
INGREDIENTS (17)
methyl salicylateActive
Quantity: 24 g in 120 g
Code: LAV5U5022Y
Classification: ACTIB
mentholActive
Quantity: 8.4 g in 120 g
Code: L7T10EIP3A
Classification: ACTIB
capsaicinActive
Quantity: 0.6 g in 120 g
Code: S07O44R1ZM
Classification: ACTIB
CARBOMER COPOLYMER TYPE AInactive
Code: 71DD5V995L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
PEG-150 DISTEARATEInactive
Code: 6F36Q0I0AC
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT