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VALENCIA, Calif. — Wet Platinum Premium Personal Lubricant has gained Section 510(k) medical device approval from the Food and Drug Administration.
Trigg Laboratories Inc., maker of the Wet sexual enhancement brand, said Tuesday that the FDA clearance enables the 100% silicone, latex-friendly product to be marketed in interstate commerce as similar to other legally marketed predicate products.
The approval also means that Wet Platinum meets the provisions of the Federal Food, Drug and Cosmetics Act for good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
According to Trigg, Wet Platinum is doctor-recommended, guaranteed to never be sticky and the brand’s longest-lasting formula. The company said Wet Platinum never dries and leaves the skin feeling soft and moisturized and, because the lubricant doesn’t break down in water, it can be used in the bath, shower or spa as well as for body massages and skin conditioning.
"Since our company was founded in 1989, we have advocated safe sex practices and are committed to providing adults with top-quality, fully effective lubricant products," stated Michael Trigg, founder and chief executive officer of Trigg Laboratories. "This new FDA approval of our 510(k) submission will enable us to continue expanding our national marketing, while assuring retailers and consumers that Wet Platinum, like all our Wet products, will continue to meet the clinical standards that have made it doctor-recommended and adult-preferred."
Last month, Trigg announced a new look for its Wet personal lubricants and intimacy products lineup. Each of the brand’s formulas was upgraded, including Wet Original, Wet Light, Wet Warming, Wet Platinum, Wet Flavored, Wet Fun Flavors 4-in-1, Wet together and Wet Pheromone. Also, the company said Wet Gellee, Wet Original and Wet Flavored are now paraben-free. Plans call for a "total revamp" of the glycerin-free and paraben-free Wet Naturals formulas in 2014, Trigg added.
Wet sexual wellness products are sold at such drug, food and mass retail chains at Walgreens, CVS/pharmacy, Rite Aid, H-E-B, Shoppers Drug Mart and Target.
