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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated June 2, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)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 bacterial contamination and prevent infection and for the temporary relief of pain and itching 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 for more than 7 days
    • condition persists or gets worse
    • 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 one or more pumps 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

    • store at 20°- 25°C (68°-77°F)
    • See card or pump for lot number and expiration date
    • one pump contains .05±.01 grams
  • Inactive ingredients

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

  • Questions?

    Call 1-877-745-6888 or visit www.myxcin-ab.com

  • PRINCIPAL DISPLAY PANEL - 10 g Blister Pack

    New!

    MAXIMUM STRENGTH

    MYXCIN™-AB

    Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

    FIRST AID ANTIBIOTIC CREAM
    Plus PAIN & ITCH RELIEF

    Neat
    Fingertip
    Dose Pump!

    Helps Heal, Protect
    & Relieve Itching in:

    • Cuts
    • Scrapes
    • Burns

    ADVANCED
    WOUND
    MANAGEMENT ™

    OVER
    200
    PUMPS

    0.35 oz (10 g)

    Principal Display Panel - 10 g Blister Pack
  • INGREDIENTS AND APPEARANCE
    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:52426-220-041 in 1 BLISTER PACK
    110 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B07/01/2011
    Labeler - Phoenix Global Supply Group, Inc. (843189908)
    Establishment
    NameAddressID/FEIBusiness Operations
    SGS Life Science Services093840643ANALYSIS
    Establishment
    NameAddressID/FEIBusiness Operations
    Xellia Pharmaceuticals ApS305814345MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacia and UpJohn Company829076566API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Syn-Tech Chem. & Pharm. Co., Ltd.656002532API MANUFACTURE
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