Version
v4
Effective date
October 1, 2025
Original packager
—
Sections captured
14
Identifiers
- Document ID
- ab77047c-733c-45c0-af68-a1829f36a8f8
- Set ID
- ac5b585c-050d-44a2-80d2-642597dc8892
- Application numbers
- 333B
- Product NDCs
- 68788-8270
- Package NDCs
- 68788-8270-2
- Original packager NDCs
- 0113-0084
Names & Manufacturers
- Brand names
- Good Sense First Aid Antibiotic
- Generic names
- BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B
- Manufacturer names
- Preferred Pharmaceuticals Inc.
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
- Routes
- TOPICAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- 204602
- UNII
- 057Y626693, 19371312D4, 89Y4M234ES
- UPC
- —
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active ingredients (in each gram) Bacitracin zinc equivalent to 400 units bacitracin Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate
Ask Doctor Or Pharmacist (1)
Sequence 1
Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns
Do Not Use (1)
Sequence 1
Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body
Dosage And Administration (1)
Sequence 1
Directions • clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage
Inactive Ingredient (1)
Sequence 1
Inactive ingredients cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum
Indications And Usage (1)
Sequence 1
Use first aid to help prevent infection in minor: • cuts • scrapes • burns
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Package Label Principal Display Panel (1)
Sequence 1
Principal Display Panel Original Ointment Triple Antibiotic Long Lasting Infection Protection Helps skin heal to look healthy DOCTOR RECOMMENDED #1 combination of active ingredients Original Ointment First Aid Antibiotic Bacitracin Zinc – Neomycin Sulfate – Polymyxin B Sulfate Compare to active ingredients of Neosporin® 100% SATISFACTION GUARANTEED NET WT 0.5 OZ (14 g) Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8270-2 Triple Antibiotic Ointment
Purpose (1)
Sequence 1
Purpose First aid antibiotic
Questions (1)
Sequence 1
Questions or comments? 1-800-719-9260
Spl Product Data Elements (1)
Sequence 1
Good Sense First Aid Antibiotic bacitracin zinc, neomycin, polymyxin B BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM COCOA BUTTER COTTONSEED OIL OLIVE OIL SODIUM PYRUVATE .ALPHA.-TOCOPHEROL ACETATE Translucent
Stop Use (1)
Sequence 1
Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops
Storage And Handling (1)
Sequence 1
Other information • store at 20-25°C (68-77°F)
Warnings (1)
Sequence 1
Warnings For external use only. Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
OpenFDA raw payload
{'application_number': ['333B'],
'brand_name': ['Good Sense First Aid Antibiotic'],
'generic_name': ['BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B'],
'manufacturer_name': ['Preferred Pharmaceuticals Inc.'],
'original_packager_product_ndc': ['0113-0084'],
'package_ndc': ['68788-8270-2'],
'product_ndc': ['68788-8270'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['TOPICAL'],
'rxcui': ['204602'],
'spl_id': ['ab77047c-733c-45c0-af68-a1829f36a8f8'],
'spl_set_id': ['ac5b585c-050d-44a2-80d2-642597dc8892'],
'substance_name': ['BACITRACIN ZINC',
'NEOMYCIN SULFATE',
'POLYMYXIN B SULFATE'],
'unii': ['89Y4M234ES', '057Y626693', '19371312D4']}