TRIPLE ANTIBIOTIC- bacitracin zinc and neomycin and polymyxin b sulfate ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (each gram contains:)
Bacitracin zinc 500 units
Neomycin 3.5 mg
Polymyxin B sulfate 10,000 units

PURPOSE

Purpose
antibiotic

INDICATIONS & USAGE

Uses
First aid to help prevent the risk of infection in minor

• cuts
• scrapes
• burns
  

WARNINGS

Warnings
For external use only.

DO NOT USE

Do not use

• in the eyes
• over large areas of the body
• if you are allergic to any of the ingredients
• longer than one week unless directed by a doctor

ASK DOCTOR

Ask a doctor
before use in case of deep or puncture wounds, animal bites, or serious burns

STOP USE

Stop use and ask a doctor if

• the condition persists or gets worse
• a rash or other allergic reaction develops
  

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

Inactive ingredients:  Melaleuca Oil (T36-C5 (R)), mineral oil, petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin zinc and neomycin and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-291
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 U  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 U  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-291-01	14 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	07/01/1995

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		079711683	manufacture(54473-291)