TRIBIOTIC

TRIBIOTIC

Drug Labeling and Warnings

Drug Details

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TRIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
HART Health

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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TRIBIOTIC

Active Ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base)

Polymyxin B Sulfate 5,000 units

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

Uses: First aid to help prevent infection and temporarily relieve pain in
  • minor cuts
  • scrapes
  • burns
  • abrasions

Warnings: For external use only

Serious burns require immediate medical attention


Allergy alert: Do not use if you are allergic to any of the ingredients

do not use

  • in or near the eyes
  • over large portions of the body
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition worsens or lasts for more than 7 days
  • a rash or other allergic reaction occurs

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions:

Do not use more than directed.

Adults and children 12 years of age and over:

  • clean the affected area
  • apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 12 years of age: ask a doctor

Petrolatum

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TRIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50332-0032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400   in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000   in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50332-0032-610 in 1 BOX, UNIT-DOSE
1.5 g in 1 PACKET
2NDC: 50332-0032-325 in 1 BOX, UNIT-DOSE
2.5 g in 1 PACKET
3NDC: 50332-0032-5144 in 1 BOX, UNIT-DOSE
3.5 g in 1 PACKET
4NDC: 50332-0032-110 in 1 BOX, UNIT-DOSE
4.9 g in 1 PACKET
5NDC: 50332-0032-225 in 1 BOX, UNIT-DOSE
5.9 g in 1 PACKET
6NDC: 50332-0032-4144 in 1 BOX, UNIT-DOSE
6.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/03/2005
Labeler - HART Health (069560969)
Registrant - HART Health (069560969)
Establishment
NameAddressID/FEIBusiness Operations
WaterJel Technologies155522589manufacture(50332-0032)

Revised: 10/2012
 
HART Health


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