TOPCARE  BACITRACIN ZINC- bacitracin zinc ointment 
Topco Associates LLC

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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TopCare®
Bacitracin Zinc

Drug Facts

Active ingredient (each gram contains)

Bacitracin Zinc 500 units

Purpose

First aid antibiotic

Uses

first aid to help prevent infection in

Warnings

For external use only

Do not use

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

Ask a doctor before use

  • on deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • 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

Other information

Inactive ingredients

mineral oil, white petrolatum

QUESTIONS?

1-888-423-0139

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

TopCare®

FIRST AID ANTIBIOTIC

Bacitracin Zinc
Ointment USP

QUALITY
GUARANTEED

NET WT 1 OZ (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
TOPCARE   BACITRACIN ZINC
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-089
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin) Bacitracin500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
mineral oil 
petrolatum 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-089-021 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B05/11/2006
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-089)

Revised: 1/2013
Document Id: b948c617-0f26-4692-b537-b83c98f0dccb
Set id: 5b59e26d-cc25-49a6-ac8b-f79398e18f2d
Version: 1
Effective Time: 20130108
 
Topco Associates LLC