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Triple Antibiotic Plus Pain Relief

Medically reviewed on September 28, 2017

Dosage form: ointment
Ingredients: Bacitracin Zinc 500[iU] in 1g, Neomycin Sulfate 3.5mg in 1g, Polymyxin B Sulfate 10000[iU] in 1g, Pramoxine Hydrochloride 10mg in 1g
Labeler: Phoenix Global Supply Group, Inc
NDC Code: 52426-120

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.

Triple Antibiotic
Ointment + Pain Relief

Drug Facts

Active ingredients
(each gram contains)
Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine HCI 10 mgExternal analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition persists or gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days
  • 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
  • adults and children 2 years of age and older:
    • 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
  • children under 2 years of age: consult a doctor

Other information
  • To open: unscrew cap, pull tab to remove foil seal.
  • store at 20°-25°C (68°-77°F)
  • See carton or tube crimp for lot number and expiration date.

Inactive ingredient

white petrolatum

Questions?

Call 1-877-745-6888

Distributed by:
Phoenix Global Supply Group, Inc.
White Plains, NY 10604

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Triple Antibiotic
Ointment + Pain Relief
Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic / Pain Relieving Ointment

Maximum Strength

NET WT 1 oz (28.4 g)

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52426-120
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin Zinc) Bacitracin Zinc500 [iU]  in 1 g
Neomycin Sulfate (Neomycin) Neomycin Sulfate3.5 mg  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate10000 [iU]  in 1 g
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:52426-120-051 TUBE (TUBE) in 1 CARTON
114.2 g in 1 TUBE
2NDC:52426-120-061 TUBE (TUBE) in 1 CARTON
228.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/23/2010
Labeler - Phoenix Global Supply Group, Inc (843189908)
Establishment
NameAddressID/FEIOperations
SGS Life Science Services093840643ANALYSIS
Establishment
NameAddressID/FEIOperations
Axellia Pharmaceuticals ApS305814345MANUFACTURE
Establishment
NameAddressID/FEIOperations
Pharmacia and UpJohn Company829076566MANUFACTURE
Establishment
NameAddressID/FEIOperations
Syn-Tech Chem. & Pharm. Co., Ltd.656002532API MANUFACTURE
Establishment
NameAddressID/FEIOperations
Axellia Pharmaceuticals AS561816174MANUFACTURE

 
Phoenix Global Supply Group, Inc

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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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