Label: ANTIBIOTIC AND PAIN RELIEF MAXIMUM STRENGTH- bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl ointment

  • 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 11, 2012

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    (in each gram)

    Bacitracin zinc 500 units

    Neomycin 3.5 mg

    Polymyxin B sulfate 10,000 units

    Pramoxine hydrochloride 10 mg

  • PURPOSES

    First aid antibiotic/Pain reliever

  • USES

    Helps prevent infection in and temporarily relieves pain due to

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    For external use only

    Allergy alert:

    • do not use if allergic to any of the ingredients
  • DO NOT USE

    • in or near the eyes
    • on large areas of the body
  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • deep or puncture wounds
    • animal bites
    • serious burns
  • WHEN USING THIS PRODUCT

    • do not use longer than 1 week
  • STOP USE AND ASK A DOCTOR IF

    • condition lasts or gets worse
    • symptoms last for more than 7 days or clear up and come back within a few days
    • a rash or other allergic reaction occurs
  • 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 and older:

    • clean affected area
    • apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily
    • may be covered with a sterile bandage

    Children under 2 years: ask a doctor

  • INACTIVE INGREDIENT

    White petrolatum

  • QUESTIONS?

    1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday-Friday.

    Store at 59º - 86ºF (15º - 30ºC).

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    *Compare to the active ingredients in Neosporin®+ Pain Relief

    Preferred plus ++++ Pharmacy

    ANTIBIOTIC + PAIN RELIEF

    MAXIMUM STRENGTH OINTMENT

    BACITRACIN ZINC – NEOMYCIN SULFATE - POLYMYXIN B SULFATE - PRAMOXINE HCl

    FIRST AID ANTIBIOTIC /PAIN RELIEVING OINTMENT

    NET WT 1 OZ (28 G)

    INFECTION PROTECTION

    FOR BURNS, CUTS & SCRAPES

    Maximum Strength Pain Relief Ointment

    08230209A1 VC109276

    e7bfff6a-figure-01
    e7bfff6a-figure-02

    CARTON LABEL

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC AND PAIN RELIEF  MAXIMUM STRENGTH
    bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE10000 [USP'U]  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:63777-082-311 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/01/2010
    Labeler - Kinray, Inc. (012574513)