ProcureTriple Antibiotic Triple Antibiotic: Package Insert and Label Information

PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
TWIN MED, LLC

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.

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 15 o — 30 o C(59 o- -86 o F)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet is torn, cut or opened.

Inactive Ingredients

White Soft Paraffin

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 400 U in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 5000 U in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55681-216-01 0.9 g in 1 PACKET None
2 NDC:55681-216-02 28.3 g in 1 TUBE None
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 — TWIN MED, LLC (009579330)

Revised: 08/2022 TWIN MED, LLC

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