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Insight Pharmaceuticals launches new suite of products: Monistat Complete Care

BY Michael Johnsen

TREVOSE, Pa. — Insight Pharamceuticals on Wednesday announced the launch of a new suite of products — Monistat Complete Care — that offers women solutions to maintain their vaginal health. The new product portfolio includes the Vaginal Health Test, a one-step test that can determine if an infection is present; Probiotics plus Antioxidants, which contains the only probiotic strains that are clinically proven to help maintain both urinary tract and vaginal health; and Stay Fresh Feminine Freshness Gel, an easy-to-use, odor-neutralizing gel that lasts for up to three days. 
 
These new products join the popular Chafing Relief Powder Gel and Instant Itch Relief Cream that are now under the Complete Care banner.
 
"While Monistat has been synonymous with yeast infection treatment for years, there is so much more to vaginal health that women both want and need to know about," said Jennifer Moyer, VP marketing for Insight Pharmaceuticals. "Our new Complete Care products give women the tools they need to be in greater control of their health in the comfort and privacy of their own home."
 
Though yeast infections are common in women and can be treated with an over-the-counter product like Monistat, many women suffer from other vaginal infections that may require attention from a physician. With the new Monistat Complete Care Vaginal Health Test, women can now determine if their infection is consistent with that of a yeast infection or if they should seek care from a healthcare professional. The simple swab, which is the same accurate test used by doctors, changes color in seconds to indicate signs of abnormal vaginal pH, which can indicate an infection. 
 
"Even in today's culture of oversharing, many women find it difficult to ask their doctors questions about their vaginal health," said Yvonne Bohn, OB/GYN and author. "Being informed about your own health is the most powerful tool you can have in making sure you receive the care you need. Putting a screening test in women's hands that uses the same technology doctors use is an empowering advancement for women and their vaginal health."
 
Moyer noted that many women have concerns over non-infection related vaginal issues. "Vaginal infections of any kind can make women feel uncomfortable, but research has shown that feminine odor is a huge source of insecurity," she said. "That's why we've introduced a new product that is unlike any other — a feminine freshness gel that doesn't just mask, but actually neutralizes odor."
 
The Monistat Complete Care Stay Fresh Feminine Freshness Gel helps to eliminate feminine odor with a paraben-free, easy-to-use formula. As the only OTC product specifically designed to match healthy vaginal pH levels and relieve feminine odor, one application delivers results that last for up to three days. Additionally, the gel stays in place so it's not messy for women to use. 
 
Also included in the new suite of products is Monistat Complete Care Probiotics plus Antioxidants, a proactive approach to vaginal health. The oral capsule, taken daily, contains the only probiotic strains clinically proven to help maintain both urinary and vaginal health. Paired with antioxidants (Vitamin A and Vitamin C) to support the immune system, the capsule contains lactobacillus reuteri and lactobacillus rhamnosus, which have shown to be effective in managing recurring urinary tract infections and recurring yeast infections.
 
"With most other probiotics, it is not clear how much benefit actually reaches the vaginal canal," Bohn said. "With the probiotics in Complete Care Probiotics Plus Antioxidants, studies were done which showed that the probiotics reached the vaginal canal and helped maintain the normal vaginal balance."
 

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Four steps to prevent mosquito bites and the diseases that come with them

BY Ryan Chavis

BALTIMORE — The summer months continue to bring hot weather and — when you add summer rainfall to the mix — bothersome mosquitos. It's an unfortunate reality that during this time of year mosquitos are at their peak. And as the mosquito population increases, so do the chances of getting bitten by them, some of which may be carrying diseases.

"Exposure to mosquitoes increases the risk of painful mosquito bites and the risk of West Nile virus and other mosquito-borne diseases," said mosquito expert Jonathan Cohen, president of Summit Responsible Solutions. "Because mosquitoes carry West Nile virus, and because every state in the continental USA has reported cases of West Nile virus during the past two years, it's important to avoid being bitten at all."

There are steps that consumer can take to better prevent being bitten and to protect themselves from diseases like West Nile Virus:

  • Drain it: Any containers that can hold water are a hot spot for mosquitos to breed. That means draining kids' swimming pools, wheelbarrows, plant saucers and buckets. Changing the water in pet dishes and replacing water in bird baths frequently is also recommended;
  • Dress smart: Clothing provides a barrier between consumers and a mosquito. Wear long sleeves and pants to prevent bites. Wearing a hat also helps to prevent bites;
  • Dawn and Dusk: Try to avoid being outside at dawn or dusk — these are times when mosquitos are at their peak; and
  • Deter: Use repellents to deter mosquiotos and keep them at bay.

"Knowing a little bit about mosquitoes can help prevent painful and potentially dangerous mosquito bites," Cohen said. "Knowing that female mosquitoes lay their eggs in standing water and draining standing water is a key to keeping mosquito populations down. Avoiding contact with mosquitoes whenever possible will also greatly reduce the chances of getting bitten."

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FDA shuts down Long Island company for non-compliance to dietary supplement cGMPs

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday shut down a company for noncompliance of the dietary supplement current good manufacturing practice requirements. 
 
"Triceutical of Farmingdale, New York, and Liqun Zhang, the company’s president, have agreed to stop production and distribution of dietary supplements under the terms of a consent decree because of violations of federal dietary supplement regulations," the agency stated. "Triceutical, under the FDA’s supervision, is required to recall and destroy all dietary supplements that were manufactured, prepared, packed, repacked, labeled, held and/or distributed since Feb. 6, 2012, in accordance with the procedures in the consent decree. The consent decree was entered by U.S. District Judge Leonard Wexler of the Eastern District on July 8, 2014."
 
The FDA issued Triceutical a warning letter dated Nov. 8, 2012, that outlined serious violations of cGMP requirements, including failure to perform tests to verify the identity of dietary ingredients used to manufacture the dietary supplements. Follow-up inspections by the FDA revealed that Triceutical failed to take adequate corrective actions to correct that violation and to ensure the manufacturing process complied with cGMP requirements. Failure to follow cGMP requirements made Triceutical’s products adulterated under the Federal Food, Drug and Cosmetic Act.
 
“When a company violates good manufacturing practice requirements, they put consumers at risk,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “Our goal at the FDA is to ensure that the dietary supplements consumers have access to meet federal standards for safety, effectiveness and quality."
 

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