Label: BACITRACIN ZINC AND POLYMYXIN B SULFATE - bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 52959-054-03, 52959-054-07, 52959-054-44
- Packager: H.J. Harkins Company, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0168-0021
- 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 August 29, 2011
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- Drug Facts
- Active ingredients (in each gram)
Bacitracin Zinc (equal to 500 bacitracin units)
Polymyxin B Sulfate (equal to 10,000 polymyxin B units)Close
- For external use only
Stop use and ask a doctor if
- the condition persists or gets worse
- if a 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
- do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal • store at room temperature
- see crimp of tube for Lot No. and Exp. date
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER
Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444
- INGREDIENTS AND APPEARANCE
BACITRACIN ZINC AND POLYMYXIN B SULFATE
bacitracin zinc and polymyxin b sulfate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-054(NDC:0168-0021) 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 Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate 1000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52959-054-03 14.17 g in 1 TUBE 2 NDC:52959-054-07 28.34 g in 1 TUBE 3 NDC:52959-054-44 144 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/06/2010 Labeler - H.J. Harkins Company, Inc. (147681894) Establishment Name Address ID/FEI Business Operations Nycomed US Inc. 174491316 MANUFACTURE Establishment Name Address ID/FEI Business Operations Nycomed US Inc. 043838424 ANALYSIS, MANUFACTURE