Label: FIRST AID TRIPLE ANTIBIOTIC AND PAIN RELIEF MAXIMUM STRENGTH- bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrocloride 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 August 23, 2010

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!