MedPath
FDA Approval

Tripleantibioticointmentandpainrelief

May 12, 2025

HUMAN OTC DRUG LABEL

Bacitracin(500 [USP'U] in 100 g)
Neomycin(3.5 mg in 100 g)
Polymyxin B(10000 [USP'U] in 100 g)

Products (1)

Tripleantibioticointmentandpainrelief

69396-061

M004

OTC Monograph Drug (C200263)

TOPICAL

May 12, 2025

PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
Code: 58H6RWO52IClass: ACTIBQuantity: 500 [USP'U] in 100 g
NeomycinActive
Code: 057Y626693Class: ACTIBQuantity: 3.5 mg in 100 g
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 100 g
Code: 88AYB867L5Class: ACTIBQuantity: 10 mg in 100 g

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

430702-FBA GLOBE TRIPLE ANTIBIOTIC OINTMENT PAIN RELIEF 1OZ 2PK BOX 111824 CDER JW


INDICATIONS & USAGE SECTION

Uses

First Aid to help prevent infection in minor:

  • Cuts
  • Scrapes
  • Burns

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean the affected area thoroughly
  • 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

WARNINGS SECTION

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

STORAGE AND HANDLING SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Pramoxine HCL 10mg

OTC - PURPOSE SECTION

Purpose

External Analgesic

OTC - ASK DOCTOR SECTION

Ask a Doctor before Use

Ask Doctor before use if you have:

  • Deep or puncture wouns
  • Animal bites
  • Serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children

If Swallowed, get medical help or contact a Poison Control Center right away

OTC - STOP USE SECTION

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

OTC - QUESTIONS SECTION

Questions?

Call 1-888-296-9067


SPL UNCLASSIFIED SECTION

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 8801304-FBA

INACTIVE INGREDIENT SECTION

Inactive Ingredient:

Petrolatum


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