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The CryoFreeze Wart and Skin Tag Remover is intended for the over-the-counter treatment of common warts and plantar warts in individuals ages 4 years and older and the over-the-counter treatment of skin tags in individuals ages 22 and older.

The CryoFreeze Wart and Skin Tag Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common warts, plantar warts, and skin tags. The device includes:

• A pressurized aerosol canister filled with a liquid mixture of compressed gases
• 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.

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