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ProcureTriple Antibiotic Triple Antibiotic

Dosage form: ointment
Ingredients: BACITRACIN ZINC 400U in 1g, NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 5000U in 1g
Labeler: TWIN MED, LLC
NDC Code: 55681-216

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.

Drug Facts

Active Ingredients(in each gram)Bacitracin Zinc............400 units
Neomycin Sulfate 5mg(equivalent to 3.5 mg Neomycin)
Polymyxin B Sulfate .. 5000 units

PurposeFirst Aid Antibiotic

UsesFirst 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 IngredientsWhite Soft Paraffin

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


PROCURETRIPLE ANTIBIOTIC  TRIPLE ANTIBIOTIC
bacitracin zinc neomycin sulfate polymyxin b ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-216
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN400 U  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B5000 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:55681-216-010.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/05/2013
Labeler - TWIN MED, LLC (009579330)
Registrant - Sion Biotext Medical Ltd (532775194)

Revised: 02/2013
 
TWIN MED, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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