Products (1)
Tripleantibioticointmentandpainrelief
69396-061
M004
OTC Monograph Drug (C200263)
TOPICAL
May 12, 2025
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
BacitracinActive
Code: 58H6RWO52IClass: ACTIBQuantity: 500 [USP'U] in 100 g
NeomycinActive
Code: 057Y626693Class: ACTIBQuantity: 3.5 mg in 100 g
Polymyxin BActive
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
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