Label: MEIJER 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 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 December 12, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients                                                                          Purpose

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

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

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

  • PURPOSE

    Uses

    first aid to help prevent infection and 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 persits 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 the 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 affeted area
    • apply a small amount (equal to surface area of tip of a finger) on area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 yeras 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

    emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, propylparaben, purified water, white petrolatum

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MEIJER ANTIBIOTIC PLUS PAIN RELIEF 
    neomycin sulfate, polymyxin b sulfate, and pramoxine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-943
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-943-141 in 1 CARTON01/19/2015
    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 finalpart34701/19/2015
    Labeler - Meijer, Inc. (006959555)