ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream 
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.

----------

Antibiotic
Cream + Pain Relief

Drug Facts

Active ingredients
(each gram contains)
Purpose
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine HCl 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 ingredients

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, 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

Antibiotic
Cream + Pain Relief
Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic / Pain Relieving Cream

Maximum Strength

NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
ANTIBIOTIC PLUS PAIN RELIEF 
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52426-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
petrolatum (UNII: 4T6H12BN9U)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52426-220-051 in 1 CARTON
114.2 g in 1 TUBE
2NDC:52426-220-061 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

Revised: 9/2010
Document Id: 5328de28-f628-4f1c-b03e-03ad9a98c796
Set id: 25668cbf-b3b6-4825-9aeb-be0bb7d776d1
Version: 1
Effective Time: 20100928
 
Phoenix Global Supply Group, Inc.