Label: UEC MEDICAL FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-391-20, 65923-391-21, 65923-391-44, 65923-391-45 - Packager: United Exchange Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 6, 2018
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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)