BACITRACIN ZINC- bacitracin zinc ointment 
Anicare Pharmaceuticals Pvt. Ltd

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 Ointment

Active Ingredient

Bacitracin Zinc 500 units

Purpose

First aid antibiotic

USES

First aid to help prevent infection in

WARNINGS

EXTERNAL USE ONLY

DO NOT USE

Before using, consult a doctor if you have

STOP USE and ask a doctor if

KEEP OUT OF REACH OF CHILDREN

If swallowed get medical help or contact a Poison Control Center immediately.

DIRECTIONS

Other information

Keep carton, it contains important information.

Lot No./Exp. Date: see crimp of tube.

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

PRINCIPAL DISPLAY PANEL

Bacitracin Zinc Ointment

NET WT 0.5 OZ (14g)

Bacitracin Zinz Ointment
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-155
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
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47046-155-021 in 1 CARTON12/09/2020
1NDC:47046-155-0114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/09/2020
Labeler - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(47046-155)

Revised: 12/2020
Document Id: b65a3425-3169-7d41-e053-2995a90af59d
Set id: b65a2a1e-b5cb-e47d-e053-2995a90a6abc
Version: 1
Effective Time: 20201213
 
Anicare Pharmaceuticals Pvt. Ltd