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Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness. Provides long lasting relief for up to 6 hours.

The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device). The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.

Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness. Provides long lasting relief for up to 4 hours.

The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device). The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.

The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene. The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.

The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.

For the temporary management of stress urinary incontinence (SUI) in women

The device is a single use vaginal pessary, inserted into the vagina, by the user, using a tampon-like applicator. The device is composed of a high density polyethylene core, a nonwoven overwrap, and a withdrawal cord. The overwrap helps to facilitate ease of insertion and removal. The device is removed by a withdrawal cord made from tampon withdrawal cord material. Upon removal, the device is disposed of in a trash receptacle. The pessary is a single-use device. It is designed for daily use up to 12 hours in 24 hours. The device is available in one size and is sold over-the-counter.

The Oral-B® Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis. The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

The Oral-B® Test Drive Power Brush Trial Program is designed to introduce potential users to a power toothbrush as a means to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis. The program kit that is used in the trial program contains a power toothbrush consisting of a rechargeable handle, charger, replacement brush heads, and instructions for the proper use and care of the device. Additionally, the program kit contains plastic dental sheaths to prevent soiling of the multi-user handle and instructions for cleaning and disinfection of the reusable handle. The program kit is indicated for use as an introductory trial to a power toothbrush under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

The TAMPAX® M Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.

The TAMPAX® L Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.

The TAMPAX® V Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.

The TAMPAX® C Plastic™ Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Unscented menstrual tampons for absorption of menstrual fluid

TAMPAX® Pearl Plastic Applicator Unscented Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, an overwrap, a withdrawal cord, an absorbent braid, and an applicator.