Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
- NDC Code(s): 71205-600-28
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 61269-179
- 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 August 1, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredients (in each gram)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredient
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- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
NDC 71205-600-28
*Compare to the active ingredients in
Neosporin® Original OintmentTriple Antibiotic Ointment
Bacitracin zinc | Neomycin sulfate | Polymyxin B sulfate Ointment
First aid antibioticFor external use only
First aid antibiotic to help prevent infection in minor cuts, scrapes, and burnsNet wt. 1 oz (28 g)
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-600(NDC:61269-179) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400 [USP'U] in 1 g 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 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength WHITE PETROLATUM (UNII: B6E5W8RQJ4) Product Characteristics Color YELLOW (light yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-600-28 1 in 1 CARTON 08/18/2021 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 05/24/2021 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(71205-600)