PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b ointment

ProcureTriple Antibiotic by

Drug Labeling and Warnings

ProcureTriple Antibiotic by is a Otc medication manufactured, distributed, or labeled by TWIN MED, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients(in each gram)

Bacitracin Zinc............400 units
Neomycin Sulfate 5mg(equivalent to 3.5 mg Neomycin)
Polymyxin B Sulfate .. 5000 units

Purpose

First Aid Antibiotic

Uses

First aid to prevent infection in

• Minor cuts
• Scrapes
• Burns
  

Directions

• Clean the affected area
• Apply small amount of this product(an amount equal to the surface area of the tip of the finger on the area 1 to 3 times daily
• May be covered with a sterile bandage
  

Warnings

For External Use Only.

Do not use

• In the eyes
• If you are allergic to any of the ingredients
• Over large areas of the body
• Longer than 1 week unless directed by a doctor
• Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns
  

Stop use and ask a doctor if

• The condition persists or gets worse
• A rash or allergic reaction develops
  

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Centre right away
  

Other information

• Store at controlled room temperature 15o - 30oC(59o--86o F)
• Avoid excessive heat and humidity
• Tamper Evident
• Do not use if packet is torn, cut or opened.
  

Inactive Ingredients

White Soft Paraffin

Principal Display Panel

ProCure
Triple Antibiotic Ointment
First Aid  Antibiotic
144 PACKETS
Net Weight: 0.9 grams
Item No. PCTA09
NDC # 55681-261-01

INGREDIENTS AND APPEARANCE

PROCURETRIPLE ANTIBIOTIC  TRIPLE ANTIBIOTIC
bacitracin zinc neomycin sulfate polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 U  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 U  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-216-01	0.9 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	02/05/2013

Labeler - TWIN MED, LLC (009579330)

Registrant - Sion Biotext Medical Ltd (532775194)