Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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POLVOS DE SULPHA FIRST AID ANTIBIOTIC - bacitracin zinc, polymyxin b sulfate powder 
Menper Distributors Inc.

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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Drug Facts

Uses

First aid to help prevent infection in minor:

  • Cuts
  • Scrape
  • Burns

Warnings

For external use only

Do not use

  • in the eyes
  • if you allergic to any of the ingredients
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • the 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

adults and children 2 years of age or older:

  • clean the affected area
  • apply a light dusting of the powder on the area 1 to 3 times daily
  • maybe be covered with a sterile bandage
children under 2 years of age: consult a doctor

Other information:

  • store at 15 C (59 to 77F)
  • do not refrigerate

Inactive Ingredient Lactose

Active Ingredients

(each gram contains)                      Purpose

Bacitracin Zinc 500 units               First aid antibiotic

Polymyxin B Sulfate                     First aid antibiotic

PolvosdeSulphaLabel

POLVOS DE SULPHA  FIRST AID ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53145-304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN ZINC - UNII:89Y4M234ES) BACITRACIN ZINC500   in 7.5 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE10000   in 7.5 g
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53145-304-047.5 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/11/2006
Labeler - Menper Distributors Inc. (101947166)
Registrant - Menper Distributors Inc. (101947166)

Revised: 5/2011
 
Menper Distributors Inc.


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