Label: POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF- bacitracin, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride 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 October 27, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredients                                                                                                                 Purpose

    Bacitracin 500 units per gm-------------------------------------------------------------------------First Aid Antibiotic

    Neomycin 3.5 mg per gm---------------------------------------------------------------------------First Aid Antibiotic

    Polymyxin B 10,000 units per gm------------------------------------------------------------------First Aid Antibiotic

    Pramoxine Hydrochoride 10mg---------------------------------------------------------------------First Aid Antibiotic

  • PURPOSE

    Uses

    First aid to help prevent infection in and temporarily relieve pain due to minor:

    Cuts, Scrapes, Burns

  • WARNINGS

    For external use only

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

  • DO NOT USE

    Do not use

    in or near the eyes or nose

    on large areas of the body

  • ASK DOCTOR

    Ask a doctor before use if you have

    deep or puncture wounds

    animal bites

    serious burns

  • WHEN USING

    do not use longer than 1 week

  • STOP USE

    Stop use and ask a doctor if

    condition lasts or gets worse

    symptoms last more than 7 days or clear up and occur again within a few days

    a rash or other allergic reaction occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center immediately.

  • 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 the area 1 to 3 times daily.

    May be covered with a sterile bandage

    Children 2 years and under: ask a doctor

  • STORAGE AND HANDLING

    Other information

    Store at controlled room temperature at 68°-77° (20°-25°)

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Genomma lab USA Inc.,

    Houston, TX, 77027

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF 
    bacitracin, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    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
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-013-141 in 1 CARTON10/27/2016
    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 finalpart333B06/30/2014
    Labeler - Genomma Lab USA, Inc. (832323534)