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  1. Medication Health Fraud

Public Notification: XXX Zone Platinum Contains Hidden Drug Ingredients

[6/23/2017] The Food and Drug Administration is advising consumers not to purchase or use XXX Zone Platinum, a product manufactured by SHH Trading and promoted for sexual enhancement on various websites and possibly sold in some retail stores.

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  XXX Zone Platinum Product

FDA laboratory analysis confirmed that XXX Zone Platinum contains sildenafil, tadalafil and dapoxetine. Sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, are used to treat erectile dysfunction. These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Dapoxetine is an active ingredient not approved by FDA, therefore its safety and efficacy have not been established.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.

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