TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment 
Phoenix Global Supply Group, Inc

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.

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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:

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

Other information

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)

Principal Display Panel - 28.4 g Tube Carton
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES) Bacitracin Zinc500 [iU]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate10000 [iU]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52426-120-051 in 1 CARTON
114.2 g in 1 TUBE
2NDC:52426-120-061 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/FEIBusiness Operations
SGS Life Science Services093840643ANALYSIS
Establishment
NameAddressID/FEIBusiness Operations
Axellia Pharmaceuticals ApS305814345MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Pharmacia and UpJohn Company829076566MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Syn-Tech Chem. & Pharm. Co., Ltd.656002532API MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Axellia Pharmaceuticals AS561816174MANUFACTURE

Revised: 9/2010
Document Id: b0f4a5d9-9d8a-4f62-ba9d-3d383989323a
Set id: 2c8b5a71-51cf-4274-aacc-411dfd1f05e5
Version: 1
Effective Time: 20100928
 
Phoenix Global Supply Group, Inc