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Package Insert and Label Information: Triple Antibiotic

By Melaleuca, Inc. | Last revised: 31 December 2010

TRIPLE ANTIBIOTIC — bacitracin zinc, neomycin and polymyxin b sulfate ointment
Melaleuca, Inc.

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.

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

Purpose
antibiotic

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

  • cuts
  • scrapes
  • burns

Warnings
For external use only.

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

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.
If swallowed, get medical help or contact a Poison Control Center immediately.

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

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TRIPLE ANTIBIOTIC bacitracin zinc and neomycin and polymyxin b sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-578
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN ZINC) BACITRACIN ZINC 500 [iU] in 1 g
NEOMYCIN (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 10000 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
Tea Tree Oil
MINERAL OIL
Petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54473-578-01 14 g in 1 TUBE None
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 Operations
Melaleuca, Inc. 139760102 manufacture

Revised: 12/2010 Melaleuca, Inc.