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

TRIBIOTIC by

Drug Labeling and Warnings

TRIBIOTIC by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

INDICATIONS & USAGE

Uses: First aid to help prevent infection and temporarily relieve pain in

• minor cuts
• scrapes
• burns
• abrasions

WARNINGS

Warnings: For external use only

Serious burns require immediate medical attention

ADVERSE REACTIONS

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

DO NOT USE

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 DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns
  

STOP USE

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

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  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	10/03/2005
1		.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0032-3	25 in 1 BOX, UNIT-DOSE	10/03/2005
2		.5 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 50332-0032-5	144 in 1 BOX, UNIT-DOSE	10/03/2005
3		.5 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 50332-0032-1	10 in 1 BOX, UNIT-DOSE	10/03/2005
4		.9 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 50332-0032-2	25 in 1 BOX, UNIT-DOSE	10/03/2005
5		.9 g in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 50332-0032-4	144 in 1 BOX, UNIT-DOSE	10/03/2005
6		.9 g in 1 PACKET; Type 0: Not a Combination Product

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)