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


Triple Antibiotic

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.

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Triple Antibiotic

Active ingredient (in ea. gram)                                                Purpose           
Bacitracin Zinc 400 Units                                                                      antibacterial

Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)                         antibacterial

Polymyxin B Sulfate 5000 Units                                                            antibacterial

Uses triple antibiotic :

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)
  • avoid excessive heat and humidity
  • Tamper Evident. Do not use if packet is torn, cut or open.

Inactive ingredients:

White petrolatum

Directions triple antibiotic:

  •  clean 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

KEEP OUT OF REACH OF CHILDREN  If swallowed, get medical help or contact a Poison Control Center right away.

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

Warnings

For external use only

Principal Display Panel

Triple Antibiotic

triple_antibiotic


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:67777-240
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:67777-240-01 12 BOX ( BOX) in 1 CASE contains a BOX
1 144 PACKET ( PACKET) in 1 BOX This package is contained within the CASE (67777-240-01) and contains a PACKET
1 0.5 g in 1 PACKET This package is contained within a BOX and a CASE (67777-240-01)
2 NDC:67777-240-02 12 BOX ( BOX) in 1 CASE contains a BOX
2 144 PACKET ( PACKET) in 1 BOX This package is contained within the CASE (67777-240-02) and contains a PACKET
2 0.9 g in 1 PACKET This package is contained within a BOX and a CASE (67777-240-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 03/16/2011

Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 03/2011 Dynarex Corporation



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


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