StopsBleeding™ is FDA Approved in the United States for topical applications where there is minor to severe bleeding. Examples of this could be: On a cervix that was accessed through the vagina, or on the colon accessed through the rectum. Other applications could be severe nosebleeds, removing skin cancers, warts, and moles, and oral applications in the mouth. StopsBleeding™ has not been approved in the United States for surgical use inside the body's cavity. To do so would be considered an off-label use. StopsBleeding™ is also approved for Emergency Room severe bleeding applications and has been granted a labelling claim, by the FDA, as “Safe in the Wound.” Example: Someone's arm or leg has been severely cut by a knife or a chainsaw.