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BACITRACIN ZINC by STRATUS PHARMACEUTICALS INC

Medically reviewed on Nov 2, 2017

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[USP'U] in 1g, POLYMYXIN B SULFATE 10000[USP'U] in 1g
Labeler: STRATUS PHARMACEUTICALS INC
NDC Code: 58980-012

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)Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Polymyxin B 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

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

When using this product
  • do not use longer then one week unless directed by doctor

Ask a doctor before use if you have
  • deep or puncture wounds
  • animal bites
  • serious burns

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

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

Directions
  • Clean the affected area
  • Apply a small amount of this product on the area 1 to 3 times
  • May be covered with a sterile bandage

Other information
  • Store at room temperature
  • Before using any medication, read all label directions.

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 - 0.9 g Packet Box

NDC 58980-012-01

STRATUSCARE
Double Antibiotic
Ointment

(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

Distributed by:
STRATUS
PHARMACEUTICALS INC

1 GROSS

Net Wt. 0.9g (1/32 oz) PACKETTES

BACITRACIN ZINC 
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-012
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 
Product Characteristics
ColorWHITE (OFF WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58980-012-01144 PACKET in 1 BOX
10.9 g in 1 PACKET
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(58980-012), LABEL(58980-012), PACK(58980-012)

 
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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