BACITRACIN ZINC- bacitracin zinc ointment 
STRATUS 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

Drug Facts

Active ingredient (in each gram)

Bacitracin Zinc, USP 500 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

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

Other information

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

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorWHITE (OFF WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-011-101 in 1 BOX09/15/2017
128.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:58980-011-01144 in 1 BOX05/15/2020
21 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/15/2017
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIBusiness Operations
TARMAC PRODUCTS INC059890491MANUFACTURE(58980-011) , LABEL(58980-011) , PACK(58980-011)

Revised: 5/2020
Document Id: d63c8e51-f999-4e81-bd4c-d7814b7655eb
Set id: b2cb3a96-b0ca-42ee-8056-91d5450fb376
Version: 2
Effective Time: 20200504
 
STRATUS PHARMACEUTICALS INC