BACITRACIN- bacitracin 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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1162_1163_Bacitracin_Ointment

Active ingredient               Purpose
Bacitracin 500 Units                Antibiotic

Warnings:

For external use only

Dosage and 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.

Do not use:

  • 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

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

Indications and Usage

Ask a doctor before use:

Other information

Inactive ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Bacitracin Ointment:

bacitracin-galentic-ointment-01.jpg

1162_1163_Bacitracin_Ointment

BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-219
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-219-0172 in 1 CASE
128.35 g in 1 TUBE
2NDC:67777-219-0472 in 1 CASE
214.17 g in 1 TUBE
3NDC:67777-219-0612 in 1 CASE
3144 in 1 BOX
30.5 g in 1 PACKET
4NDC:67777-219-0712 in 1 CASE
4144 in 1 BOX
40.9 g in 1 PACKET
5NDC:67777-219-0572 in 1 CASE
556.7 g in 1 TUBE
6NDC:67777-219-0272 in 1 CASE
6113.4 g in 1 TUBE
7NDC:67777-219-0312 in 1 CASE
7425.3 g in 1 JAR
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)

Revised: 5/2014
Document Id: eb0099e9-bf25-48df-b434-17eb039c31da
Set id: e8e4f5e5-0506-4a68-b9b7-19c48b9ae053
Version: 4
Effective Time: 20140506
 
Dynarex Corporation