sunmark® double antibiotic

sunmark® double antibiotic

Drug Labeling and Warnings

Drug Details

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SUNMARK  DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment 
McKesoon

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.

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sunmark®
double antibiotic

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 the 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49348-274-721 in 1 CARTON12/05/1990
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B12/05/1990
Labeler - McKesoon (177667227)
Registrant - Taro Pharmaceutical U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-274)

Revised: 2/2018
 
McKesoon


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