TRIPLE ANTIBIOTIC- bacitracin zinc and 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.

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Triple Antibiotic Ointment Label

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

Warnings
For external use only.

Do not use

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

Stop use and ask a doctor if

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

Directions

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

image of label

TRIPLE ANTIBIOTIC 
bacitracin zinc and neomycin and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-291
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 U  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-291-0114 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/01/1995
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079711683manufacture(54473-291)

Revised: 1/2023
Document Id: f2077821-678c-72bc-e053-2a95a90afe26
Set id: 65ae4607-689d-6056-e053-2a91aa0aff56
Version: 3
Effective Time: 20230111
 
Melaleuca, Inc.