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The device is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber and polyisoprene condoms. Not compatible with polyurethane condoms.

Vaginal Moisturizing Gel is a non-sterile, water based, colorless, transparent viscous gel. It is identical to the predicate devices except that it is packaged for use in tube sizes of either 5 or 50 grams (0.18oz. /1.8 oz.). Tubes are comprised of a laminate structure. The larger 50 gram size will utilize a flip-top cap while the smaller 5 gram size will utilize a screw on cap. This device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. The following parameters are included as part of the device specification: - Appearance - Color - Odor - pH - Viscosity - Osmolality - Antimicrobial effectiveness - Total Aerobic Microbial Count (TAMC) - Total Yeast and Mold Count (TYMC) - Absence of Pathogenic Organisms (at minimum Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans)

The device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms.

Vaginal Moisturizing Gel is identical to the predicate device except that it is presented in 8 pre-filled applicators for easy use. Vaginal Moisturizing Gel is intended for use as a personal lubricant. This product is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. The following parameters are included as part of the product specification: • Appearance • Color • Odor • pH • Viscosity • Osmolality • Antimicrobial effectiveness • Total Aerobic Microbial Count (TAMC) • Total Yeast and Mold Count (TYMC) • Absence of Pathogenic Organisms (at minimum Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans) Vaginal Moisturizing Gel has a pH of 4.5-5.0 and a shelf life of 18

The device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with polyisoprene condoms. This device is not compatible with natural rubber latex or polyurethane condoms.

Internal Hydrating Gel is a colorless, transparent, aqueous, hydrating gel in tube with 8 syringes for easy application. Internal Hydrating Gel is intended for use as a personal lubricant. This product is compatible with polyisoprene condoms. This device is not compatible with natural rubber latex or polyurethane condoms. Accordingly, the following parameters are included as part of the product specification: Appearance, Color, Odor, pH, Viscosity, Osmolality, Antimicrobial effectiveness, Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), Absence of Pathogenic Organisms (at minimum Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans). Internal Hydrating Gel has a pH of 4.5-5.0 and a shelf life of 21 months.