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Compound W® Skin Tag Remover is intended for the OTC treatment of skin tags in adults age 22 years or older.

Compound W® Skin Tag Remover is a cryogenic device intended to remove acrochordons (skin tags) via epidermal cryotherapy, destroying target epidermal cells by using extremely cold temperatures. The device contains a non-replaceable, non-refillable aluminum canister holding the gases dimethyl ether and propane. Activation of the device ejects a dose of the gases into a disposable polyurethane foam applicator tip, resulting in freezing of the applicator to approximately -30°C. The cold applicator tip is placed on the skin tag, thus destroying the target tissue. Each Compound W® Skin Tag Remover device is supplied in a paperboard carton with eight disposable tips, plastic tweezers, adhesive "Tag Target" skin-protecting discs, and an Instructions-for-Use leaflet.

The DenTek Ultimate™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

The DenTek Ultimate™ Dental Guard is a one-piece, posterior-occlusion dental guard consisting of two moldable bite-pads connected by a flexible band that rests behind the user's front teeth. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's maxillary pre-molars after the guard has been heated via submersion in boiled water. The DenTek Ultimate™ Dental Guard is supplied pre-loaded into a flexible molding tray that allows the user to accurately place and comfortably hold the heated device during the molding process. When in place, the guard maintains separation between upper and lower teeth, reducing noise and damage to the teeth associated with teeth grinding.

Compound W® Nitro-Freeze is intended for over-the-counter treatment of common warts and plantar warts in adults and children four years of age or older.

Compound W® Nitro-Freeze is a pen-like cryogenic device that utilizes pressurized nitrous oxide (N,O, liquefied) to destroy wart tissue through evaporative cooling when the cryogen is delivered via a disposable foam applicator tip. Each Compound W® Nitro-Freeze device is supplied in an outer carton with an Instructions-for-Use leaflet and a bag containing replacement tips.

Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age or older.

The Nix® Ultra Lice Treatment Kit consists of two components: Nix® Ultra Lice Killing Solution and Nix® Ultra Lice Removal Comb. The kit also includes an Instructions for Use Leaflet. Nix® Ultra Lice Killing Solution is a formulated device containing dimethicone and isoparaffin. The product kills lice and their eggs by physically coating the lice and clogging the spiracles through which they breathe and conduct water exchange; the solution also lubricates the hair to facilitate removal of dead lice and nits with the supplied comb. The Nix® Ultra Lice Treatment Kit is intended for over-the-counter use.

For the over-the-counter removal of common and plantar warts.

The Compound W® Wart Removal System Dual Power is a cryosurgical system for the over-the-counter removal of common and plantar warts. Compound W® Wart Removal System Dual Power consists of the following: - O Pressurized aerosol spray canister with a mixture of dimethyl ether and propane (K032271) - o Reusable actuator/cap that releases the cryogen onto the disposable applicators - Disposable foam applicators O - Salicylic acid gel wart remover provided in a squeeze tube (in compliance with OTC O monograph 21 CFR 358 subpart B) - O Comfort pads - Instruction Leaflet o