Label: FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hci cream

  • 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 January 31, 2019

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

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)                                                                                 Purpose

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

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

    Pramoxine hydrochloride 10mg ...................................................................................Pain reliever

  • 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 (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions Adults and children 2 years and older:

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

    Children under 2 years: ask a doctor

  • STORAGE AND HANDLING

    Other information

    • Store between 20 oC and 25 oC (68 oF and 77 oF)
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetanol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearic acid

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Midwood Brands, LLC

    10811 Monroe Rd.

    Matthews, NC 28105

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    3326

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    neomycin sulfate, polymyxin b sulfate, and pramoxine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-033
    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
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-033-281 in 1 CARTON10/15/2012
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B10/15/2012
    Labeler - FAMILY DOLLAR (024472631)