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BACITRACIN ZINC by STRATUS PHARMACEUTICALS INC

Medically reviewed on October 23, 2017

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[USP'U] in 1g
Labeler: STRATUS PHARMACEUTICALS INC
NDC Code: 58980-011

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.

BACITRACIN ZINC

Drug Facts

Active ingredient (in each gram)

Bacitracin Zinc, USP 500 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy alert
  • do not use if allergic to any of the ingredients

Do not use
  • in the eyes
  • over large areas 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 longer then one week unless directed by doctor

Stop use and ask a doctor if
  • condition persists or gets worse
  • a rash or other allergic reaction develop

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • 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
  • May be covered with a sterile bandage

Other information
  • Store at room temperature 59°F - 77°F (15°C - 25°C)
  • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Do not use if seal is punctured or is not visible
  • See crimp of tube and outside of carton for Lot Number and Expiration Date.
  • To open, reverse cap and puncture.

Inactive Ingredient

White petrolatum

Questions or comments?

Call toll-free 1-800-442-7882

Distributed by: Stratus Pharmaceuticals Inc.
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

STRATUSCARE
NDC 58980-011-10

Bacitracin Zinc Ointment USP

First Aid Antibiotic

Net Wt. 1.0 OZ (28.35 g)

Distributed by:
STRATUS
PHARMACEUTICALS INC

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Product Characteristics
ColorWHITE (OFF WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58980-011-101 TUBE in 1 BOX
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/15/2017
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIOperations
TARMAC PRODUCTS INC059890491MANUFACTURE(58980-011), LABEL(58980-011), PACK(58980-011)

 
STRATUS PHARMACEUTICALS INC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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