Label: DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 51672-2044-2
- Packager: Taro Pharmaceuticals U.S.A., 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 December 11, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each gram) 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 cuts
For external use only
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week
Stop use and ask a doctor if
- condition persists or gets worse
- a rash or other allergic reaction develops
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- clean the affected area and dry thoroughly
- 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 between 20° and 25°C (68° and 77°F)
- see carton or tube crimp for lot number and expiration date
- Inactive ingredient
- SPL UNCLASSIFIED SECTION
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
Compare to the
active ingredients in
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:51672-2044 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:51672-2044-2 1 in 1 CARTON 09/06/2018 1 28.4 g in 1 TUBE; 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 12/05/1990 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2044)