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Name:Bacitracin
Manufacturer:Dynarex Corporation
Category:Over-the-counter (OTC) Marketed Drugs


1162_1163_Bacitracin_Ointment

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

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)

Inactive ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Bacitracin Ointment:

1162_1163_Bacitracin_Ointment



BACITRACIN 
bacitracin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-219
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN ) BACITRACIN 500 [iU]  in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL  
PETROLATUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-219-01 72 TUBE ( TUBE) in 1 CASE contains a TUBE
1 28.35 g in 1 TUBE This package is contained within the CASE (67777-219-01)
2 NDC:67777-219-04 72 TUBE ( TUBE) in 1 CASE contains a TUBE
2 14.17 g in 1 TUBE This package is contained within the CASE (67777-219-04)
3 NDC:67777-219-06 12 BOX ( BOX) in 1 CASE contains a BOX
3 144 PACKET ( PACKET) in 1 BOX This package is contained within the CASE (67777-219-06) and contains a PACKET
3 0.5 g in 1 PACKET This package is contained within a BOX and a CASE (67777-219-06)
4 NDC:67777-219-07 12 BOX ( BOX) in 1 CASE contains a BOX
4 144 PACKET ( PACKET) in 1 BOX This package is contained within the CASE (67777-219-07) and contains a PACKET
4 0.9 g in 1 PACKET This package is contained within a BOX and a CASE (67777-219-07)
5 NDC:67777-219-05 72 TUBE ( TUBE) in 1 CASE contains a TUBE
5 56.7 g in 1 TUBE This package is contained within the CASE (67777-219-05)
6 NDC:67777-219-02 72 TUBE ( TUBE) in 1 CASE contains a TUBE
6 113.4 g in 1 TUBE This package is contained within the CASE (67777-219-02)
7 NDC:67777-219-03 12 JAR ( JAR) in 1 CASE contains a JAR
7 425.3 g in 1 JAR This package is contained within the CASE (67777-219-03)

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
Establishment
Name Address ID/FEI Operations
Sion Biotext Medical 532775194 manufacture
Establishment
Name Address ID/FEI Operations
Choice Laboratories 650070394 manufacture

Revised: 07/2010 Dynarex Corporation



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


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