PERIOGELX

Manufacturer
PERIO PROTECT, LLC
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:57:27

Label at a glance#

ProductPERIOGELX
Active ingredientHYDROGEN PEROXIDE
Label structure11 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 1.7%(w/w)

Purpose

OTC - PURPOSE SECTION

Oral Debriding Agent/Oral Wound Cleanser

Approved Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

INSTRUCTIONS FOR USE SECTION

  • 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

OTHER SAFETY INFORMATION

Store at controlled room temperature (68-77ºF) in a cool, dry place away from direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethyl alcohol (5%w/w), menthol, methyl salicylate, phosphoric acid, poloxamer 407, polysorbate 20, potassium sorbate, sodium saccharin, sorbitol, water, xylitol.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Keep out of reach of children.

OTC - QUESTIONS SECTION

Call toll free 1-877-434-4867 from 9am-5pm CST/CDT Monday-Friday.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTubeBoxBoxPeriogel®X

Oral Debriding Agent/ Oral Wound Cleanser

(Hydrogen Peroxide)

Net Wt. 3 oz. (85 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1095271hydrogen peroxide 1.7 % Oral GelPSN7
2743349PerioGel 1.7 % Oral GelPSN7
2743349hydrogen peroxide 0.017 MG/MG Oral Gel [Periogel]SBD7
1095271hydrogen peroxide 0.017 MG/MG Oral GelSCD7
1095271hydrogen peroxide 1.7 % Oral GelSY7
2743349Periogel 0.017 MG/MG Oral GelSY7
2743349Periogel 1.7 % Oral GelSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrco.de/bfZAySPM5912-131 Rev001 GELX-2000.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83381-3205-1PERIOGELX85 g in 1 TUBEGEL857
83381-3205-1PERIOGELX1 in 1 BOXGEL17

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83381-320583381-3205-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC1f7ecd75-bb59-2f4f-e063-6294a90ace842026-03-31WarningsExact identifier
ndc (package): 83381-3205-1
ndc (product): 83381-3205
ndc11 (package): 83381320501
spl id: 51c8eec7-4e38-9ecc-e063-6294a90a3459
spl set id: 1f7ecd75-bb59-2f4f-e063-6294a90ace84

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.