Label: HARRIS TEETER TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- neomycin, polymyxin b, and pramoxine hcl cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 20, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)                                          Purpose

    Neomycin 3.5 mg..................................................................First aid antibiotic

    Polymyxin B 10,000 units.......................................................First aid antibiotic

    Pramoxine HCI 10 mg............................................................External analgesic

  • PURPOSE

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

    • cuts
    • scrapes
    • burns

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

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

    • 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 2 years of age and 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
  • STORAGE AND HANDLING

    Other information

    • store at 20° to 25°C (68° to 77°F)
    • lot no. & exp. date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    • cetyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, sorbitan monostearate, stearic acid, water
  • DOSAGE & ADMINISTRATION

    Distributed by:

    Harris Teeter, LLC

    Matthews, NC 28105

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HARRIS TEETER TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    neomycin, polymyxin b, and pramoxine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72036-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72036-403-141 in 1 CARTON04/20/2017
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/20/2017
    Labeler - Harris Teeter (047279351)