Label:
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- neomycin sulfate, polymyxin b sulfate and hydrocortisone suspensio...
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  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 2, 2022

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP is a sterile antibacterial and anti-inflammatory suspension for otic use. Neomycin Sulfate is the sulfate salt of neomycin ...
  • CLINICAL PHARMACOLOGY
    Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant ...
  • INDlCATlONS AND USAGE
    For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of ...
  • CONTRAINDICATIONS
    This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.
  • WARNINGS
    Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk is greater with prolonged use. Therapy should be ...
  • PRECAUTIONS
    General: As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If the infection is not improved after 1 week, cultures and ...
  • ADVERSE REACTIONS
    Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS). Adverse reactions have occurred with topical use of antibiotic combinations ...
  • DOSAGE AND ADMlNlSTRATlON
    Therapy with this product should be limited to 10 consecutive days. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 drops of ...
  • HOW SUPPLIED
    Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP is supplied in a white plastic dropper bottle in the following size: 10 mL bottles - NDC 63187-308-10 - Storage: Store at ...
  • REFERENCES
    • Jones, RN, Milazzo J, Seidlin, M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surg. 1997; 123: 1193-1200. • Leyden JJ and Kligman ...
  • Principal Display Panel
    NDC 63187-308-10 - Neomycin and - Polymyxin B Sulfates - and Hydrocortisone - Otic Suspension USP - (Sterile) [icon- ear] USE IN EARS ONLY - 10 mL - Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information