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Collagenase SANTYL Ointment 250 units/gram

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In accordance with USP standards and guidelines and data on file.
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Important Safety Information

Indication: Collagenase SANTYL Ointment (“SANTYL”) is indicated for debriding chronic dermal ulcers and severely burned areas. Contraindications: SANTYL is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase. Warnings and 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 adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics. As such, the wound should be properly cleansed prior to application of SANTYL. Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia. A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when SANTYL was not confined to the wound. SANTYL is not indicated for wound closure. Discontinue use of SANTYL after granulation tissue is well-established. Adverse Reactions: No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. The risk information provided herein is not comprehensive. To see the complete Prescribing Information, please see the FDA-approved product labeling, here: https://www.santyl.com/pdf/SANTYL-PI.pdf. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

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