POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF (BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]

POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF (BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]
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NDC 50066-013-14
Set ID f3d37827-590c-495a-8ac1-a17a12f7616c
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA, Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • 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)

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