FDA Label for Oxistom
View Indications, Usage & Precautions
Oxistom Product Label
The following document was submitted to the FDA by the labeler of this product Forward Science Technologies Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Inactive Ingredients
Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol
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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.
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