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Tripleantibioticointmentandpainrelief

Medically reviewed on November 20, 2017.

Dosage form: ointment
Ingredients: BACITRACIN 500[USP'U] in 100g, NEOMYCIN SULFATE 3.5mg in 100g, PRAMOXINE HYDROCHLORIDE 10mg in 100g, POLYMYXIN B SULFATE 10000[USP'U] in 100g
Labeler: Trifecta Pharmaceuticals USA
NDC Code: 69396-030

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.

Triple Antibiotic Ointment + Pain Relief

DRUG FACTS

Active Ingredient

Bacitracin 500 Units

Purpose

First Aid Antibiotic

Active Ingredient

Neomycin 3.5mg

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B 10,000 Units

Purpose

First Aid Antibiotic

Active Ingredient

Pramoxine HCL 10mg

Purpose

External Analgesic

Uses

First Aid to help prevent infection in minor:

  • Cuts
  • Scrapes
  • Burns

Warnings

For external use only. Do not use:

  • In eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients

Ask a Doctor before Use

Ask Doctor before use if you have:

  • Deep or puncture wouns
  • Animal bites
  • Serious burns

Stop Use and ask a Doctor if:
  • Condition persists or gets worse
  • You need to use longer than 1 week
  • A 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
  • 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 to 3 times daily
  • May be covered with a sterile bandage

Other Information
  • To Open: Unscrew cap, pull tab to remove foil seal
  • Store at 20° to 25°C (68° to 77°F)
  • See carton or tube crimp for lot number and expiration date

Inactive Ingredient:

Light mineral oil, Petrolatum

Questions?

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF 
bacitracin,neomycin,polymxin, pramoxine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (BACITRACIN) BACITRACIN500 [USP'U]  in 100 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE3.5 mg  in 100 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 100 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B10000 [USP'U]  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
LIGHT MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:69396-030-011 TUBE in 1 BOX
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/20/2017
Labeler - Trifecta Pharmaceuticals USA (079424163)

 
Trifecta Pharmaceuticals USA

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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