Oral Wound Cleanser

FDA Drug Profile — PRO-SYS, OxiStom

Drug Details

Generic Name
Oral Wound Cleanser
Brand Names
PRO-SYS, OxiStom
Application Number
M022
Sponsor
Forward Science Technologies LLC
NDC Codes
4
Dosage Forms
LIQUID
Routes
DENTAL
Active Ingredients
HYDROGEN PEROXIDE

Indications and Usage

Uses • Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth. • For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. • For temporary use to cleanse canker sores. • Assists in the removal of foreign material from minor oral wounds.

Warnings

Warnings Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product, do not swallow. Stop use and ask a dentist or physician if: • sore mouth symptoms do not improve in 7 days; • irritation, pain, or redness persists or worsens; • swelling, rash, or fever develops.