Label: DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 62011-0097-1
- Packager: Health Mart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
- if you are allergic to any of the ingredients
- over large areas of the body
- 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.
- see carton or tube crimp for lot number and expiration date
- store at room temperature
- Inactive ingredient
- SPL UNCLASSIFIED SECTION
Distributed by McKessonClose
One Post Street, San Francisco, CA 94104
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
compare to Polysporin®
helps prevent infection in
minor cuts, scrapes, and burns.
double antibiotic ointment
• 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:62011-0097 Route of Administration TOPICAL DEA Schedule 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:62011-0097-1 1 in 1 CARTON 1 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 03/21/2012 Labeler - Health Mart (177667227) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(62011-0097)