Label: ANTIBIOTIC AND PAIN RELIEF- bacitracin, neomycin, polymyxin b, pramoxine hcl ointment

  • NDC Code(s): 11822-0444-1, 11822-0444-2, 11822-0444-3
  • Packager: Rite Aid Corporation
  • 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 8, 2017

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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 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 ingredient

    white petrolatum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredients of Neosporin® + Pain Relief

    MAXIMUM STRENGTH

    first aid antibiotic + pain relief ointment

    bacitracin zinc – neomycin sulfate – polymyxin B sulfate – pramoxine HCl

    first aid antibiotic/pain relieving ointment

    helps prevent infection and for temporary relief of pain due to minor cuts, scrapes and burns

    NET WT 1 OZ (28 g)

    antibiotic + pain relief ointment image
  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC AND PAIN RELIEF 
    bacitracin, neomycin, polymyxin b, pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0444
    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) NEOMYCIN3.5 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)  
    Product Characteristics
    ColorYELLOW (Translucent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0444-11 in 1 CARTON02/18/2009
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11822-0444-21 in 1 CARTON08/17/2005
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11822-0444-32 in 1 CARTON06/08/2017
    328 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/17/2005
    Labeler - Rite Aid Corporation (014578892)
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