FDA.reportPublic FDA data

Perio Plus

Manufacturer
Gingi-Pak a Division of the Belport | Jeff Nichols
Effective date
2022-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:18

Label at a glance#

ProductPerio Plus
Active ingredientHYDROGEN PEROXIDE
Label structure10 sections

Indications 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.

Dosage and administration

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 den...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 1.7% (w/w)

Purpose

OTC - PURPOSE SECTION

Wound Cleanser

Indications and Uses

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Ethyl Alcohol, Menthol, Methyl Salicylate, Phosphoric Acid, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Sodium Saccharin, Sorbitol, Water

Warning

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use Perio Armor for more than 7 days unless directed by your dentist or physician.

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children.

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Perio Max+Perio Max+

Principla Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Perio Plus MintPerio Plus Mint

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1095271hydrogen peroxide 1.7 % Oral GelPSN2
1095271hydrogen peroxide 0.017 MG/MG Oral GelSCD2
1095271hydrogen peroxide 1.7 % Oral GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10129-044-032025-01-30C16284748780-12cef2736-616b-d83d-e063-dadaa90ab31fPerio Max Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10129-043-03Perio Plus1 in 1 BOXGEL12
10129-043-03Perio Plus86 g in 1 TUBEGEL862
10129-044-03Perio Max Plus86 g in 1 TUBEGEL862
10129-044-03Perio Max Plus1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10129-043PERIO PLUS (1.7% HYDROGEN PEROXIDE) GEL PERIO MAX PLUS (1.7% HYDROGEN PEROXIDE) GEL [GINGI-PAK A DIVISION OF THE BELPORT]2Legacy NDC, 2 package rows20221102_e7a27f6e-b4fa-0f8d-e053-2995a90a0975.zip
10129-044PERIO PLUS (1.7% HYDROGEN PEROXIDE) GEL PERIO MAX PLUS (1.7% HYDROGEN PEROXIDE) GEL [GINGI-PAK A DIVISION OF THE BELPORT]2Legacy NDC, 2 package rows20221102_e7a27f6e-b4fa-0f8d-e053-2995a90a0975.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10129-04410129-044-03
10129-04310129-043-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
ALCOHOL3K9958V90MIACT
PHOSPHORIC ACIDE4GA8884NNIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 207T1F30V5YHIACT
METHYL SALICYLATELAV5U5022YIACT
MENTHOLL7T10EIP3AIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
ALCOHOL3K9958V90MIACT
PHOSPHORIC ACIDE4GA8884NNIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 207T1F30V5YHIACT
METHYL SALICYLATELAV5U5022YIACT
MENTHOLL7T10EIP3AIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
ebe0fc4c-ba0c-79a2-e053-2995a90affece7a27f6e-b4fa-0f8d-e053-2995a90a09752022-10-25WarningsExact identifier
spl id: ebe0fc4c-ba0c-79a2-e053-2995a90affec
spl set id: e7a27f6e-b4fa-0f8d-e053-2995a90a0975

Reported adverse events (FAERS/openFDA)#

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