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Name:Bacitracin
Manufacturer:Preferred Pharmaceuticals, Inc
Category:Over-the-counter (OTC) Marketed Drugs


BACITRACIN   - bacitracin zinc ointment 
Preferred Pharmaceuticals, 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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Bacitracin zinc 500 units ......First Aid Antibiotic

Help prevent infection in

  • minor cuts
  • scrapes
  • burns

If swallowed, get medical help or contact a Poison Control Center right away

Helps prevent infection in

  • Minor cuts
  • Scrapes
  • Burns

  • Clean affected area
  • apply small amount (equal to surface area of tip of finger) on area 1 to 3 times daily
  • may be covered with a sterile bandange

For external use only

Warnings
Allergy Alert:  do not use if allergic to any of the ingredients
Do Not Use:
  • In eyes      
  • On large parts of the body
Ask a doctor before use if you have:
  • deep or puncture wounds
  • animal bites
  • serious burns
When using this product:
  • do not use for more than 1 week
Stop us and ask doctor if:
  • condition lasts or gets worse
  • rash or other allergic reaction occurs

White Petralatum

Relabeled by Preferred Pharmaceuticals, Inc

Anaheim, CA 92807

image of bacitracin label


BACITRACIN  
bacitracin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0191(NDC:0472-1105)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN ZINC) BACITRACIN ZINC 500 ng  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-0191-2 28 g in 1 TUBE None
2 NDC:68788-0191-1 14 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 12/03/2010

Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc 791119022 repack

Revised: 03/2011 Preferred Pharmaceuticals, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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