BACITRACIN ZINC- bacitracin zinc ointment 
Taro Pharmaceuticals U.S.A., 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 (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?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Bacitracin Zinc
Ointment USP
First Aid Antibiotic Ointment

NET WT 1 oz (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2075
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
mineral oil (UNII: T5L8T28FGP)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2075-11 in 1 CARTON05/11/2006
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-2075-21 in 1 CARTON05/11/2006
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B05/11/2006
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2075)

Revised: 1/2020
Document Id: 5a5a8e07-1943-46c6-9c73-4a3a666f868d
Set id: 4afdeedf-9cdf-47d6-919f-ea907fda0290
Version: 3
Effective Time: 20200122
 
Taro Pharmaceuticals U.S.A., Inc.