Label: TRIPLE ANTIBIOTIC AND BURN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment

  • NDC Code(s): 69842-432-58, 69842-432-64
  • Packager: CVS Pharmacy
  • 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 October 25, 2022

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  • Active ingredients (in each gram)

    Bacitracin zinc 500 units

    Neomycin sulfate equivalent to 3.5 mg of neomycin base

    Polymyxin B 10,000 units as polymyxin B sulfate

    Pramoxine HCl 10 mg

  • Purpose

    First aid antibiotic

    External analgesic

  • Uses

    first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

    •
    cuts
    •
    scrapes
    •
    burns
  • Warnings

    For external use only

    Do not use

    •
    if you are allergic to any of the ingredients
    •
    in the eyes
    •
    over large areas of the body

    Ask a doctor before use if you have

    •
    deep or puncture wounds
    •
    animal bites
    •
    serious burns

    Stop use and ask a doctor if

    •
    you need to use longer than 1 week
    •
    condition persists or gets worse
    •
    symptoms persist for more than 1 week, or clear up and occur again within a few days
    •
    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 (1-800-222-1222).

  • Directions

    •
    adults and children 2 years of age or older:
    •
    clean the affected area
    •
    apply a small amount 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: ask a doctor
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    white petrolatum

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    CVS Health®

    Compare to the active ingredients in Neosporin® + Burn Relief

    MAXIMUM STRENGTH OINTMENT

    Triple Antibiotic & Burn Relief

    BACITRACIN ZINC

    NEOMYCIN SULFATE

    POLYMYXIN B SULFATE

    PRAMOXINE HCl

    First aid antibiotic/pain relieving ointment

    Infection protection and burn pain relief

    BURN CARE

    Contains One Tube

    NET WT 0.5 OZ (14 g)

    Triple Antibiotic & Burn Relief Carton Image 1
    Triple Antibiotic & Burn Relief Carton Image 2
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC AND BURN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-432
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [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 B10000 [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:69842-432-581 in 1 CARTON03/05/2021
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69842-432-641 in 1 CARTON10/25/2022
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/05/2021
    Labeler - CVS Pharmacy (062312574)
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