Label: DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 0536-1174-20, 0536-1174-28
- Packager: Rugby Laboratories
- 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 March 27, 2019
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- Drug Facts
- Active ingredients (in each gram)
Bacitracin zinc, USP 500 unitsClose
Polymyxin B sulfate, USP 10,000 units
First aid antibioticClose
First aid to help prevent infection in
- minor cuts
For external use only
Stop use and ask a doctor if
- condition persists or gets worse
- 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 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
- Store at 15° to 25°C (59° to 77°F).
- Before using any medication, read all label directions. Keep carton, it contains important information.
- Inactive ingredient
1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.Close
- Principal Display Panel
Compare to the active ingredients in Polysporin®*
Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment, USP)
First Aid Antibiotic
First Aid to Help Prevent Infection in Minor Cuts, Scrapes, and Burns
Net wt. 0.5 oz (14g)Close
• Protection Against Infection
• For Minor Cuts, Scrapes, and Burns
- INGREDIENTS AND APPEARANCE
bacitracin zinc and polymyxin b sulfate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1174 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:0536-1174-20 1 in 1 CARTON 03/20/2019 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0536-1174-28 1 in 1 CARTON 03/25/2019 2 28 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 03/20/2019 Labeler - Rugby Laboratories (079246066) Registrant - Teva Pharmaceuticals USA, Inc. (001627975)