Label: DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 0168-0021-09, 0168-0021-31, 0168-0021-35
- Packager: E. Fougera & Co. a division of Fougera 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.
Updated February 12, 2013
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- Drug Facts
- Active ingredients (in each gram)
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
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CARTON
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON
INGREDIENTS AND APPEARANCE
bacitracin zinc and polymyxin b sulfate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) 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 500 [USP'U] in 1 g Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [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:0168-0021-35 1 in 1 CARTON 1 14.17 g in 1 TUBE 2 NDC:0168-0021-31 1 in 1 CARTON 2 28.35 g in 1 TUBE 3 NDC:0168-0021-09 1 in 1 CARTON 3 0.9 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/06/2010 Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)