Your browser does not support JavaScript! SUNMARK DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [MCKESSON]
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SUNMARK DOUBLE ANTIBIOTIC (bacitracin zinc and polymyxin b sulfate) ointment
[McKesson]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredients (in each gram)Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

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

Ask a doctor before use

  • on deep or puncture wounds, animal bites, or serious burns

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.

Directions

  • 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 at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

Questions?

Call 1-866-923-4914

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark™

double antibiotic ointment
Bacitracin Zinc-Polymyxin B Sulfate

FIRST AID ANTIBIOTIC

NET WT 1 OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
SUNMARK   DOUBLE ANTIBIOTIC
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-274
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin zinc (Bacitracin) Bacitracin500 [USP'U]  in 1 g
Polymyxin B sulfate (Polymyxin B) Polymyxin B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:49348-274-721 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B03/21/2012
Labeler - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-274)

Revised: 02/2013
Document Id: 9a8897f4-132d-44d4-a3d8-483956e7b84a
Set id: 2868de5c-4894-45ee-9647-9acd3bde7cfc
Version: 1
Effective Time: 20130204
 
McKesson

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