Label: POLYSPORIN- polymyxin b sulfate and bacitracin zinc powder
- NDC Code(s): 58232-4033-1
- Packager: Johnson & Johnson Consumer 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.
Updated May 7, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
For external use only.
Stop use and ask a doctor if
- you need to use longer than 1 week
- condition persists or gets worse
- rash or other allergic reaction develops
- Other information
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL - 10g Bottle Label
INGREDIENTS AND APPEARANCE
polymyxin b sulfate and bacitracin zinc powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58232-4033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [USP'U] in 1 g Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58232-4033-1 1 in 1 CARTON 06/14/2010 12/01/2023 1 10 g in 1 BOTTLE; 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 06/14/2010 12/01/2023 Labeler - Johnson & Johnson Consumer Inc. (002347102)