Inactive Ingredients
Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol
Pro-sys Liquid
FDA Label NDC 70275-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Forward Science Technologies Llc for the product Pro-sys (NDC 70275-201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredients, questions?, active ingredient, purpose, other information, uses, warnings, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Questions?
1-855-696-7254
Active Ingredient
Hydrogen Peroxide 1.5% (w/v)
Purpose
Oral Debriding Agent / Oral Wound Cleanser
Other Information
Store at controlled room temperatures 68 - 77°F (20 - 25°C) and away from direct sunlight. Keep cap tightly closed when not in use.
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
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.
Keep Out Of Reach Of Children
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out.
• Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician.
• Children under 12 years of age should be supervised in the use of the product.
• Children under 2 years of age: Consult a dentist or physician.
• Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out.
• Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician.
• Children under 12 years of age should be supervised in the use of the product.
• Children under 2 years of age: Consult a dentist or physician.
Package Label.Principal Display Panel
Oxistom (Ox 1006v1 2 Oxistom 13 5oz Bottle Rev Small)
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