NDC | 65923-391-20, 65923-391-21, 65923-391-44, 65923-391-45 |
Set ID | 69237c1b-4a71-8f93-e053-2991aa0a1b02 |
Category | HUMAN OTC DRUG LABEL |
Packager | United Exchange Corp. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
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ACTIVE INGREDIENT
Active ingredients Purpose
Bacitracin zinc 400 units..............................................................First aid antibiotic
Neomycin sulfate 5 mg (equivalent to 3.5 mg Neomycin)............First aid antibiotic
Polymyxin B sulfate 5,000 units...................................................First aid antibiotic
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UEC MEDICAL FIRST AID ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-391 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-391-20 20 in 1 BOX 04/04/2016 1 0.5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:65923-391-44 144 in 1 BOX 04/04/2016 2 0.5 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:65923-391-21 20 in 1 BOX 04/04/2016 3 0.9 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:65923-391-45 144 in 1 BOX 04/04/2016 4 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 04/04/2016 Labeler - United Exchange Corp. (840130579)