Medical Letter on the CDC & FDA
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Cosmetics
OTC progesterone cream results in significant drug exposure
July 24th, 2005
Over-the-counter (OTC) progesterone cream produces significant drug exposure compared to a Food and Drug Administration-approved oral progesterone product. According to recent research from the United States, "Progesterone products are available in prescription form as well as over-the-counter (OTC) topical preparations sold for 'cosmetic' uses. "In a randomized study design, the authors compared the drug exposure from an OTC progesterone cream to a Food and Drug Administration-approved oral preparation at the labeled daily doses recommended for each product. Twelve healthy postmenopausal women received 200 mg oral progesterone capsules once daily...
Source: Medical Letter on the CDC & FDA (2005-07-24)
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