BACITRACIN ZINC- bacitracin zinc ointment 
Dynarex Corporation

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                                               Purpose
Bacitracin Zinc (500 Units in each gram)               First Aid Antibiotic

Warnings:

For external use only

DOSAGE & ADMINISTRATION:

  • clean the affected areas, Apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily. May be covered with a sterile bandage

Stop use and ask a doctor if

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

Indications & Usage:

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

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

Purpose:

First aid to help prevent infection in minor cuts, scrapes, and burns.

Other information

Ask a doctor if

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

Inactive ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Dynarex Bacitracin Zinc Ointment:

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BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-220
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)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-220-0228.35 g in 1 TUBE; Type 0: Not a Combination Product12/01/2009
2NDC:67777-220-0314.17 g in 1 TUBE; Type 0: Not a Combination Product12/01/2009
3NDC:67777-220-04113.4 g in 1 TUBE; Type 0: Not a Combination Product12/01/2009
4NDC:67777-220-07425.3 g in 1 JAR; Type 0: Not a Combination Product12/01/2009
5NDC:67777-220-050.5 g in 1 PACKET; Type 0: Not a Combination Product12/01/2009
6NDC:67777-220-010.9 g in 1 PACKET; Type 0: Not a Combination Product12/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/01/2009
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Pvt. Ltd.864201135manufacture(67777-220)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176manufacture(67777-220)

Revised: 6/2017
Document Id: bdb18a0e-bb64-4392-a431-51995629186b
Set id: 8587c2e3-cfa9-4a58-a4bd-ce2a8bda9464
Version: 11
Effective Time: 20170615
 
Dynarex Corporation