Label: BACITRACIN ZINC ointment
- NDC Code(s): 58980-011-01, 58980-011-10
- Packager: STRATUS PHARMACEUTICALS INC
- 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 May 4, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each gram)
- Purpose
- Uses
- Warnings
- Directions
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Other information
- Store at room temperature 59°F - 77°F (15°C - 25°C)
- Before using any medication, read all label directions. Keep carton, it contains important information.
- Do not use if seal is punctured or is not visible
- See crimp of tube and outside of carton for Lot Number and Expiration Date.
- To open, reverse cap and puncture.
- Inactive Ingredient
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
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INGREDIENTS AND APPEARANCE
BACITRACIN ZINC
bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color WHITE (OFF WHITE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-011-10 1 in 1 BOX 09/15/2017 1 28.35 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58980-011-01 144 in 1 BOX 05/15/2020 2 1 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 09/15/2017 Labeler - STRATUS PHARMACEUTICALS INC (789001641) Establishment Name Address ID/FEI Business Operations TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-011) , LABEL(58980-011) , PACK(58980-011)
