Bio-Scriptives Lidum Topical Analgesic
Bio-Scriptives Lidum (Lidocaine 4%) Topical Analgesic
Approved
Approval ID
a19bb9cc-b20b-4a15-9c82-dd2544cb252d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 9, 2012
Manufacturers
FDA
Bio-Scriptives, Inc.
DUNS: 802946426
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60608-017
Application Numberpart346
Product Classification
M
Marketing Category
C73603
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 7, 2012
FDA Product Classification
INGREDIENTS (20)
LIDOCAINEActive
Quantity: 2.8 g in 56 g
Code: 98PI200987
Classification: ACTIM
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20Y
Classification: IACT
ETHYL OLEATEInactive
Code: Z2Z439864Y
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TOCOPHERSOLANInactive
Code: O03S90U1F2
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
METHYL NICOTINATEInactive
Code: 7B1AVU9DJN
Classification: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7J
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4N
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
Drug Labeling Information
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 3/7/2012
Drug Facts
Active Ingredients
Lidocaine 4%
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 3/7/2012
Purpose
Local Analgesic