You are here: Home > Over-the-counter (OTC) Drugs > B > Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate (Dynarex Corporation)

Name:Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate
Manufacturer:Dynarex Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Triple Antibiotic Ointment

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE  - bacitracin zinc, neomycin sulfate and polymyxin b sulfate 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.

----------

Triple Antibiotic Ointment

Active ingredient (in ea. gram)                                                Purpose           
Bacitracin Zinc 400 Units                                                          First Aid Antibiotic

Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)              First Aid Antibiotic

Polymyxin B Sulfate 5000 Units                                                 First Aid Antibiotic

Uses:

First aid to help prevent infection in:
  • Minor cuts
  • scrapes
  • burns

Warnings:

For external use only

Directions:

  • 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

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)
  • avoid excessive heat and humidity

Inactive ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Triple Antibiotic Ointment:


1184_1185_Triple Antibiotic Ointment


BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-217
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN ZINC) BACITRACIN ZINC 400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 5000 [iU]  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-217-01 72 TUBE ( TUBE) in 1 CASE contains a TUBE
1 28.35 g in 1 TUBE This package is contained within the CASE (67777-217-01)
2 NDC:67777-217-02 72 TUBE ( TUBE) in 1 CASE contains a TUBE
2 14.17 g in 1 TUBE This package is contained within the CASE (67777-217-02)
3 NDC:67777-217-03 72 TUBE ( TUBE) in 1 CASE contains a TUBE
3 56.7 g in 1 TUBE This package is contained within the CASE (67777-217-03)
4 NDC:67777-217-04 72 TUBE ( TUBE) in 1 CASE contains a TUBE
4 113.4 g in 1 TUBE This package is contained within the CASE (67777-217-04)
5 NDC:67777-217-05 12 BOX ( BOX) in 1 CASE contains a BOX
5 144 PACKET ( PACKET) in 1 BOX This package is contained within the CASE (67777-217-05) and contains a PACKET
5 0.5 g in 1 PACKET This package is contained within a BOX and a CASE (67777-217-05)
6 NDC:67777-217-06 1728 PACKET ( PACKET) in 1 CASE contains a PACKET
6 0.5 g in 1 PACKET This package is contained within the CASE (67777-217-06)
7 NDC:67777-217-07 12 BOX ( BOX) in 1 CASE contains a BOX
7 144 PACKET ( PACKET) in 1 BOX This package is contained within the CASE (67777-217-07) and contains a PACKET
7 0.9 g in 1 PACKET This package is contained within a BOX and a CASE (67777-217-07)
8 NDC:67777-217-08 1728 PACKET ( PACKET) in 1 CASE contains a PACKET
8 0.9 g in 1 PACKET This package is contained within the CASE (67777-217-08)
9 NDC:67777-217-09 12 JAR ( JAR) in 1 CASE contains a JAR
9 425.3 g in 1 JAR This package is contained within the CASE (67777-217-09)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 12/01/2009

Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
Name Address ID/FEI Operations
Galentic Pharma India Private Limited 918531450 manufacture

Revised: 07/2010 Dynarex Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2019 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

OTC Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback