Label: COLLAGENASE SANTYL ointment

  • NDC Code(s): 50484-010-30, 50484-010-90
  • Packager: SMITH & NEPHEW, INC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated May 17, 2019

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  • Rx only
  • DESCRIPTION
    Collagenase Santyl◊ Ointment is a sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme collagenase is derived from the ...
  • CLINICAL PHARMACOLOGY
    Since collagen accounts for 75% of the dry weight of skin tissue, the ability of collagenase to digest collagen in the physiological pH and temperature range makes it particularly ...
  • INDICATIONS AND USAGE
    Collagenase Santyl◊ Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21
  • CONTRAINDICATIONS
    Collagenase Santyl◊ Ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.
  • PRECAUTIONS
    The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme’s activity and appropriate precautions should be taken. The enzymatic activity is also ...
  • ADVERSE REACTIONS
    No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. However, one case of systemic manifestations of hypersensitivity to collagenase in a patient ...
  • OVERDOSAGE
    No systemic or local reaction attributed to overdose has been observed in clinical investigations and clinical use. If deemed necessary the enzyme may be inactivated by washing the area with ...
  • DOSAGE AND ADMINISTRATION
    Collagenase Santyl◊ Ointment should be applied once daily (or more frequently if the dressing becomes soiled, as from incontinence). When clinically indicated, crosshatching thick eschar with a ...
  • HOW SUPPLIED
    Collagenase Santyl◊ Ointment contains 250 units of collagenase enzyme per gram of white petrolatum USP. Do not store above 25°C (77°F). Sterility guaranteed until tube is opened. Collagenase ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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  • TUBE LABEL.PRINCIPAL DISPLAY PANEL
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  • INGREDIENTS AND APPEARANCE
    Product Information