TRIBIOTIC- bacitracin zinc, neomycin sulfate and 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

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

Ask a doctor before use if you have

Stop use and ask a doctor if

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:

Children under 12 years of age: ask a doctor

Petrolatum

Tribiotic5.jpg

Tribiotic5.jpg

TRIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0032
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400   in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 5000   in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50332-0032-6 10 in 1 BOX, UNIT-DOSE
1 .5 g in 1 PACKET
2 NDC:50332-0032-3 25 in 1 BOX, UNIT-DOSE
2 .5 g in 1 PACKET
3 NDC:50332-0032-5 144 in 1 BOX, UNIT-DOSE
3 .5 g in 1 PACKET
4 NDC:50332-0032-1 10 in 1 BOX, UNIT-DOSE
4 .9 g in 1 PACKET
5 NDC:50332-0032-2 25 in 1 BOX, UNIT-DOSE
5 .9 g in 1 PACKET
6 NDC:50332-0032-4 144 in 1 BOX, UNIT-DOSE
6 .9 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 10/03/2005
Labeler - HART Health (069560969)
Registrant - HART Health (069560969)
Establishment
Name Address ID/FEI Business Operations
WaterJel Technologies 155522589 manufacture(50332-0032)

Revised: 10/2012
Document Id: 42ef4a98-b629-4cbb-ad6d-2bf06cb0d7c3
Set id: d8f175f9-f526-4c73-a171-49309ca16cb0
Version: 1
Effective Time: 20121018
 
HART Health