Label: ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride 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 18, 2018

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

  • ACTIVE INGREDIENT

    Active Ingredients Purposes

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

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

    Pramoxine HCl 10 mg..............................External analgesic

  • PURPOSE

    Uses

    • first aid to help prevent infection and for the temporary relief of pain in minor:
    • cuts
    • scrapes
    • burns
  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes or nose
    • 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
    • rash or other allergic reaction develops
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • condition persists or gets worse
    • redness, irritation, swelling, or pain persists or increases
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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 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 room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?

    Call 1-800-814-8028

  • DOSAGE & ADMINISTRATION

    DIST. BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com


    MADE IN SOUTH KOREA

  • PRINCIPAL DISPLAY PANEL

    94031

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC PLUS PAIN RELIEF 
    neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-960
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 [iU]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    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:41250-960-141 in 1 CARTON12/18/2018
    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 finalpart34712/18/2018
    Labeler - Meijer, Inc. (006959555)