Label: LEADER TRIPLE ANTIBIOTIC- bacitracin, neomycin sulfate, polymyxin-b sulfate ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-273-10 - Packager: CARDINAL HEALTH
- Category: HUMAN OTC DRUG LABEL
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 January 22, 2018
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ACTIVE INGREDIENT
Active Ingredients (each gram contains) Purpose
Bacitracin 400 units ...............................................................................................First Aid Antibiotic
Neomycin Sulfate equivalent to 3.5mg of Neomycin Base ........................................First Aid Antibiotic
Polymyxin-B Sulfate 5000 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
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INGREDIENTS AND APPEARANCE
LEADER TRIPLE ANTIBIOTIC
bacitracin, neomycin sulfate, polymyxin-b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-273 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-273-10 1 in 1 CARTON 01/01/2015 1 28 g in 1 TUBE; 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 03/01/2012 Labeler - CARDINAL HEALTH (097537435)