TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF- bacitracin,neomycin,polymxin, pramoxine ointment

Tripleantibioticointmentandpainrelief by

Drug Labeling and Warnings

Tripleantibioticointmentandpainrelief by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF 
bacitracin,neomycin,polymxin, pramoxine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 100 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 100 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-030-01	1 in 1 BOX	07/20/2017
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	07/20/2017

Labeler - Trifecta Pharmaceuticals USA (079424163)