FIRST AID TRIPLE ANTIBIOTIC AND PAIN RELIEF MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCLORIDE) OINTMENT [LIFELABS, A DIVISION OF ATICO INTERNATIONAL USA

FIRST AID TRIPLE ANTIBIOTIC AND PAIN RELIEF MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCLORIDE) OINTMENT [LIFELABS, A DIVISION OF ATICO INTERNATIONAL USA
PDF | XML

NDC 51852-100-01
Set ID db368653-fce9-4773-af14-08067409529f
Category HUMAN OTC DRUG LABEL
Packager LIFElabs, a Division of Atico International USA, INC.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • First Aid Triple Antibiotic and Pain Relief (Maximum Strength)

    Active Ingredients

    Bacitracin zinc 500 units

    Neomycin 3.5 mg

    Polymyxin B sulfate 10,000 units

    Pramoxine hydrochloride 10 mg

  • PURPOSE

    Purposes

    • First aid antibiotic
    • Pain reliever
  • WARNINGS

    Warnings

    For external use only

    Allergy alert:

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

    Do not use

    • in or near eyes
    • longer than 1 week
    • on large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • condition lasts or gets worse
    • a rash or other allergic reaction occurs
    • symptoms last for more than 7 days or clear up and come back within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years and older:

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

    Children under 2 years: ask a doctor

  • STORAGE AND HANDLING

    Other information

    store at 59o - 86oF (15o - 30oC)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

  • QUESTIONS

    Questions?

    Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

  • INDICATIONS & USAGE



    Uses

    • First aid to help prevent infection in minor cuts, scrapes, and burns
    • First aid for the temporary relief of pain in minor cuts, scrapes, and burns
  • PRINCIPAL DISPLAY PANEL

    Image of Carton Label

    Image of Tube Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID TRIPLE ANTIBIOTIC AND PAIN RELIEF  MAXIMUM STRENGTH
    bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrocloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-100
    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) Neomycin Sulfate3.5 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
    Mineral Oil (UNII: T5L8T28FGP)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polyoxyl 40 Stearate (UNII: 13A4J4NH9I)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51852-100-011 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/01/2010
    Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)

Related Drugs