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The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.

The CryoFreeze Wart and Skin Taq Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes: - A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane - Applicator swabs - Detailed instructions, including illustrated descriptions To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds. The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.

The Verruca-Freeze® H cryosurgical system is indicated for use in the treatment of the following skin lesions: - · Actinic Keratosis - · Genital Warts - · Lentigo - · Molluscum Contagiosum - · Seborrheic Keratosis - · Skin Tags - · Verruca Plantaris - · Verruca Vulgaris - · Verruca Plana

The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions. The device consists of: • Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane • Polyurethane foam swabs • Detailed instructions including illustrated descriptions The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion. The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thaw time is 20-40 seconds. This treatment methodology is simple and has been an accepted by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.

The Verruca-Freeze® H cryosurgical system is indicated for use in the following skin lesions: - · Actinic Keratosis - · Genital Warts - Lentigo - Molluscum Contaqiosum - Seborrheic Keratosis - Skin Tags - · Verruca Plantaris - · Verruca Vulgaris • Verruca Plana - Verruca Plana

The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions. The device consists of: - Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane - . Polyurethane foam swabs - . Detailed instructions including illustrated descriptions The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion. The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto the lesion and held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thawing. The typical thaw time is 20-40 seconds. This treatment methodology is simple and has been an accepted practice used by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.

1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratoses, achrochordon, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna, keratoacanthoma, basal cell, bowen's disease, lentigo discreta, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi's sarcoma, and pyogenic granuloma.

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