TRIPLE ANTIBIOTIC GRX- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment 
Geritrex LLC

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 GRX

Drug Facts

Active ingredients (in each gram) Purpose
Bacitracin 400 unitsFirst aid antibiotic
Neomycin 3.5 mgFirst aid antibiotic
Polymyxin B 5,000 unitsFirst aid antibiotic

Use

first aid to help prevent infection in minor:

Warnings

For external use only.

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • rash or other allergic reaction develops

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

Directions

Other information

Inactive ingredients

Mineral oil, petrolatum

Questions?

call 1-800-736-3437

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TRIPLE ANTIBIOTIC GRX 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [iU]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-080-090.9 g in 1 POUCH; Type 0: Not a Combination Product12/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B12/01/2017
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex LLC112796248manufacture(54162-080)

Revised: 12/2017
Document Id: 75823050-801c-45ad-bf95-338c08f6c3d4
Set id: 785f209d-5c72-4435-afd8-2c2b20d9928e
Version: 1
Effective Time: 20171201
 
Geritrex LLC