Periogel

Manufacturer
QNT Anderson, LLC | Unicep Packaging, Inc.
Effective date
2022-05-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:49:35

Label at a glance#

ProductPeriogel
Active ingredienthydrogen peroxide
Label structure10 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 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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - DO NOT USE SECTION

Do not use for more than 7 days unless directed by a dentist or doctor. Spit out excess medication.

OTC - STOP USE SECTION

Stop use 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions for adults and children 2 years of age and older

DOSAGE & ADMINISTRATION SECTION

  • Apply several drops to the affected area of the mouth.
  • Allow 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-907-3746 from 9am - 5pm CST/CDT Monday-Friday.

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Periogel®

Oral Debriding Agent /
Oral Wound Cleanser

(Hydrogen Peroxide)

NET WT. 3 OZ. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1095271hydrogen peroxide 1.7 % Oral GelPSN4
2743349PerioGel 1.7 % Oral GelPSN4
2743349hydrogen peroxide 0.017 MG/MG Oral Gel [Periogel]SBD4
1095271hydrogen peroxide 0.017 MG/MG Oral GelSCD4
1095271hydrogen peroxide 1.7 % Oral GelSY4
2743349Periogel 0.017 MG/MG Oral GelSY4
2743349Periogel 1.7 % Oral GelSY4

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75908-017-28Periogel1 in 1 CARTONGEL14
75908-017-28Periogel28.3 g in 1 TUBEGEL28.34
75908-017-85Periogel85 g in 1 TUBEGEL854
75908-017-85Periogel1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75908-017PERIOGEL (HYDROGEN PEROXIDE) GEL [QNT ANDERSON, LLC]4Legacy NDC, 4 package rows20220517_30f97d9b-7551-499f-b3bb-5a658bd3a493.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
hydrogen peroxideACTIVE INGREDIENTBBX060AN9V2
hydrogen peroxideACTIVE MOIETYBBX060AN9V2
alcoholINACTIVE INGREDIENT3K9958V90M2
mentholINACTIVE INGREDIENTL7T10EIP3A2
methyl salicylateINACTIVE INGREDIENTLAV5U5022Y2
phosphoric acidINACTIVE INGREDIENTE4GA8884NN2
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M22
polysorbate 20INACTIVE INGREDIENT7T1F30V5YH2
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ42
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY2
sorbitolINACTIVE INGREDIENT506T60A25R2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75908-01775908-017-85, 75908-017-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 259 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sorbitolSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii candidate
28 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
mentholMENTHOLL7T10EIP3APOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
sorbitolSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii candidate
28 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNPASTE, DENTIFRICE / DENTALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
mentholMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ATABLET / SUBLINGUAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
sorbitolSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
mentholMENTHOLL7T10EIP3APASTE, DENTIFRICE / DENTAL4.7 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
potassium sorbatePOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates

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
4539ba00-922d-473d-8c61-2fa0c3ef5e9730f97d9b-7551-499f-b3bb-5a658bd3a4932022-05-13WarningsExact identifier
spl id: 4539ba00-922d-473d-8c61-2fa0c3ef5e97
spl set id: 30f97d9b-7551-499f-b3bb-5a658bd3a493

Reported adverse events (FAERS/openFDA)#

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