Label: POLYSPORIN- polymyxin b sulfate and bacitracin zinc powder
- NDC Code(s): 58232-4033-1
- Packager: Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, 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 June 16, 2010
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each gram) Purpose Bacitracin 500 units First aid antibiotic Polymyxin B 10,000 units First aid antibiotic
first aid to help prevent infection in minor:
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- clean the affected area
- apply a light dusting of the powder on the area 1 to 3 times daily
- may be covered with a sterile bandage
- Other information
- store at 20° to 25°C (68° to 77° F)
- do not refrigerate
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL - 10g Bottle Label
BACITRACIN ZINC • POLYMYXIN B SULFATE
First Aid Antibiotic Powder
Helps prevent infection in minor cuts, scrapes, and burns
NET WT 0.35 oz (10g)
- 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 Sulfate 10000 [USP'U] in 1 g Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc 500 [USP'U] in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58232-4033-1 1 in 1 CARTON 1 10 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333 06/14/2010 Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)