Label: DR BELLS POMADE- triple antibiotic plus pain relief ointment

  • 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 10, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (In each gram)

    Bacitracin 500

    Neomycin 3.5 mg

    Polymyxin B 10,000 units

    Pramoxine hydrochloride 10mg

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    Pain reliever

  • Uses

    First aid helps prevent infection in and temporarily relieves pain due to:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Allergy Alert:  Do not use if allergic to any of the ingredients

    Do not use

    • in or near the eyes or nose
    • on large areas of the body

    Consult a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than 1 week

    Stop use and consult a doctor if

    • condition persists or gets worse
    • symptoms last for more than 7 days or clear up and come back within a few days
    • a rash or other allergic reaction develops

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2 years and older.

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

    Children 2 years and under ask a doctor

  • Other information

    • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
  • Inactive ingredient

    White Petrolatum

  • Questions? 1-877-99 GENOM ( 43666)

  • Principal Display Panel – Carton Label

    POMADA DE LA CAMPANA

    Originial Ointment 

    First Aid Antibiotic + Pain Relief Ointment

    NET WT. 0.5 oz ( 14g)

    Principal Display Panel – Carton Label

  • Principal Display Panel – Tube Label

    Principal Display Panel – Tube Label

    POMADA DE LA CAMPANA

    Originial Ointment

    First Aid Antibiotic + Pain Relief Ointment

    Triple Antibiotic + Pain Relief

    • Bacitracin Zinc
    • Neomycin Sulfate 
    • Polymixin B Sulfate
    • Pramoxine HCL

    NET WT. 0.5 oz ( 14g)

     

     

     

     


     

  • INGREDIENTS AND APPEARANCE
    DR BELLS POMADE 
    triple antibiotic plus pain relief ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-161-511 in 1 CARTON
    114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/16/2012
    Labeler - Genomma lab USA Inc. (832323534)
    Registrant - Faria LLC dba Sheffield Pharmaceuticals (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Faria LLC dba Sheffield Pharmaceuticals151177797manufacture(50066-161)
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