Active Ingredients
Hydrogen Peroxide 1.7% (w/w)
Perio Armor-x
FDA Label NDC 10129-039
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gingi-pak A Division Of The Belport for the product Perio Armor-x (NDC 10129-039). 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 active ingredients, purpose, indication and uses, directions, other information, inactive ingredients, question or comments?, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Wound Cleanser
Indication And Uses
For temporary use in cleansing minor oral wounds and treatment of inflammation resulting from dental procedures or other irritations of the mouth and gums. Perio Armor may be used for decreasing the presence of plaque, a known factor in the development of gingivitis and tooth decay.
Directions
For children under 2 years of age, consult a dentist or physician before use. For adults and children 2 years of age or older: 1. Remove cap and cut the tip of the tube at the narrow end. 2. Apply several drops of the gel directly onto the affected area in the mouth. 3. Leave the gel on the affected area for at least 60 seconds, then spit. 4. Use up to 4 times daily after meals, at bedtime, or as directed by a dentist or physician.
Other Information
Store at room temperature between 20-25° C (68-77° F) and away from direct sunlight. Do not use if the tube has been damaged or tampered in any way.
Inactive Ingredients
Ethyl Alcohol, Menthol, Methyl Salicylate, Phosphoric Acid, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Xylitol, Sorbitol, Water
Question Or Comments?
(800)437-1514 or www.gingi-pak.com.
Otc - Do Not Use
Do not use Perio Armor-X for more than 7 days unless directed by your dentist or physician.
Otc - Stop Use
Stop use and consult your dentist or physician if: • Symptoms do not improve within 7 days • Irritation, pain, or redness persists or worsens • Swelling, rash, or fever develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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