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                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

  •  the condition persists or gets worse, or if a rash or other allergic reaction develops.

Indications & Usage:

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
  • 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
burns

Ask a doctor before use:

  • in case of deep or puncture wounds
  • animal bites
  • serious burns

Other information

  • store at controlled room temperature 15°-30° C (59°-86° F)

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 DRUG LABELItem Code (Source)NDC:67777-220
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
LIGHT MINERAL OIL 
MINERAL OIL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-220-0228.35 g in 1 TUBE
2NDC:67777-220-0314.17 g in 1 TUBE
3NDC:67777-220-04113.4 g in 1 TUBE
4NDC:67777-220-07425.3 g in 1 JAR
5NDC:67777-220-050.5 g in 1 PACKET
6NDC:67777-220-010.9 g in 1 PACKET
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
Sion Biotext Medical532775194manufacture(67777-220)
Establishment
NameAddressID/FEIBusiness Operations
Choice Laboratories650070394manufacture(67777-220)

Revised: 4/2014
Document Id: edefedf3-17cd-4858-b4a6-a8dcc51576e5
Set id: 8587c2e3-cfa9-4a58-a4bd-ce2a8bda9464
Version: 5
Effective Time: 20140423
 
Dynarex Corporation