Leader Hemorrholidal Recall

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Questions & Answers

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Side Effects & Adverse Reactions

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an elarged prostate gland

Ask a doctor or pharmacist before use if you are:

now taking a prescription drug for high blood pressure or depression

Stop use and ask a doctor if

• bleeding occurs
• condition gets worse or does not get better within 7 days
• introduction of the applicator into the rectum causes additional pain

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Directions

• children under 12 years of age: ask a doctor
• adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
• gently dry by patting or blotting with a tissue or a soft cloth before applying
• when first opening tube, remove foil seal
• for intrarectal use: remove protective cover from applicator and attach to tube
• lubricate applicator well, then gently insert applicator into the rectum
• thoroughly clean applicator and replace protective cover after each use
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• also apply ointment to external area

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History

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Other Information

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