Active Ingredient
Hydrogen Peroxide 1.7%(w/w)
Periogelx Gel
FDA Label NDC 83381-3205
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Perio Protect, Llc for the product Periogelx (NDC 83381-3205). 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 ingredient, purpose, approved uses, warnings, directions for adults and children 2 years of age and older, other information, inactive ingredients, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Debriding Agent/Oral Wound Cleanser
Approved Uses
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.
Warnings
Do not use for more than 7 days unless directed by a dentist or doctor. Spit out excess medication. Stopuse and ask a doctor 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.
Directions For Adults And Children 2 Years Of Age And Older
- Apply several drops to the affected area of the mouth.
- Allow the medication to remain in place at least 1 minute and then spit out.
- Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
- Children under 12 years of age should be supervised in the use of this product.
- Children under 2 years of age: Consult a dentist or doctor.
Other Information
Store at controlled room temperature (68-77°F) in a cool, dry place away from direct sunlight.
Inactive Ingredients
Ethyl alcohol (5%w/w), menthol, methyl salicylate, phosphoric acid, poloxamer 407, polysorbate 20, potassium sorbate, sodium saccharin, sorbitol, water, xylitol.
Dosage & Administration
Adults and children 2 years of age and older: cut tube tip close to the narrow end. Apply several drops of gel to the affected area of the mouth. Leave in place for at least one minute: spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. 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 doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Questions
Call toll free 1-877-434-4867 from 9am-5pm CST/CDT Monday-Friday.
Principal Display Panel
Periogel®X
Oral Debriding Agent/ Oral Wound Cleanser
(Hydrogen Peroxide)
Net Wt. 3 oz. (85 g)
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