DR BELLS POMADE (TRIPLE ANTIBIOTIC PLUS PAIN RELIEF) OINTMENT [GENOMMA LAB USA INC.]

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  • DR BELLS POMADE (TRIPLE ANTIBIOTIC PLUS PAIN RELIEF) OINTMENT [GENOMMA LAB USA INC.]

DR BELLS POMADE (TRIPLE ANTIBIOTIC PLUS PAIN RELIEF) OINTMENT [GENOMMA LAB USA INC.]
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NDC 50066-161-51
Set ID 5f1491f0-abea-4852-93f3-d5b22c3c5a94
Category HUMAN OTC DRUG LABEL
Packager Genomma lab USA Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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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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