Label: BACITRACIN ZINC ointment
- NDC Code(s): 61269-105-34, 61269-105-56
- Packager: H2-Pharma, LLC
- 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 February 7, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each gram)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredient
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 14 g Tube Carton
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INGREDIENTS AND APPEARANCE
BACITRACIN ZINC
bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61269-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 500 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength WHITE PETROLATUM (UNII: B6E5W8RQJ4) Product Characteristics Color WHITE (clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61269-105-34 1 in 1 CARTON 05/10/2021 07/31/2024 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:61269-105-56 1 in 1 CARTON 06/29/2021 10/31/2024 2 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 05/10/2021 10/31/2024 Labeler - H2-Pharma, LLC (028473634)