TRIPLE ANTIBIOTIC
Triple antibiotic ointment + pain relief
Approved
Approval ID
dfea6b2e-cd76-439d-a3da-64e2d8717163
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Encube Ethicals Private Limited
DUNS: 915834105
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21922-101
Application NumberM004
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (5)
BACITRACIN ZINCActive
Quantity: 500 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIM
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
PRAMOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 g
Code: 88AYB867L5
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/18/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/18/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/18/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/18/2025
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 4/18/2025
OTC - ASK DOCTOR SECTION
LOINC: 50569-3Updated: 4/18/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/18/2025
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 4/18/2025
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 4/18/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/18/2025
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 4/18/2025
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/18/2025