Label: POLY BACITRACIN- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 52426-420-05, 52426-420-06
- Packager: Phoenix Global Supply Group, 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 September 28, 2010
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (each gram contains) Purpose Bacitracin zinc 500 units First aid antibiotic Polymyxin B sulfate 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
- condition persists or gets worse
- you need to use longer than 1 week
- 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 small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
- Other information
- To open: unscrew cap, pull tab to remove foil seal.
- store at 20°-25°C (68°-77°F)
- See carton or tube crimp for lot number and expiration date.
- Inactive ingredient
- SPL UNCLASSIFIED SECTION
Phoenix Global Supply Group, Inc.
White Plains, NY 10604
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
Bacitracin Zinc • Polymyxin B Sulfate
First Aid Antibiotic Ointment
NET WT 1 oz (28.4 g)
- INGREDIENTS AND APPEARANCE
bacitracin zinc and polymyxin b sulfate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52426-420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin zinc - UNII:89Y4M234ES) Bacitracin zinc 500 [iU] in 1 g Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B sulfate 10000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52426-420-05 1 in 1 CARTON 1 14.2 g in 1 TUBE 2 NDC:52426-420-06 1 in 1 CARTON 2 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333B 09/23/2010 Labeler - Phoenix Global Supply Group, Inc (843189908) Establishment Name Address ID/FEI Business Operations Axellia Pharmaceuticals AS 561816174 MANUFACTURE Establishment Name Address ID/FEI Business Operations Axellia Pharmaceuticals ApS 305814345 MANUFACTURE