Projel-20

Manufacturer
Septodont, Inc. | Septodont Inc.
Effective date
2020-05-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:30:42

Label at a glance#

ProductProjel-20
Active ingredientBENZOCAINE
Label structure14 sections

Dosage and administration

Apply only amount needed to the oral mucosa to prevent or relieve pain. Children under 2 years of age: do not use.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Flavor, polyethylene glycol, sodium saccharin

Purpose:

OTC - PURPOSE SECTION

Oral Anesthetic intended for adults and children 2 years of age and older.

Use:

INDICATIONS & USAGE SECTION

Projel-20® is a 20% benzocaine topical anesthetic gel packaged in 60 gram jars for use in the operatory. The gel is indicated for temporary relief of pain associated with minor irritation or injury in the mouth and gums or of pain due to canker sores, denture sores or orthodontic appliances.
ProJel-20® is available in four flavors: Cherry, Pina Colada, Bubblegum and Mint.

WARNINGS

WARNINGS SECTION

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy alert: Do not use on patients with history of allergy due to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

DO NOT USE

SPL UNCLASSIFIED SECTION

• For more than 7 days unless directed by a dentist or physician
• If you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other ‘caine’ anesthetics
• For teething
• In children under 2 years of age

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

• Do not exceed recommended dosage
• Patient should not ingest or swallow
• Avoid contact with eyes
• Localized allergic reactions may occur after prolonged or repeated use
• Discontinue use if irritationinflammation or fever and infection develops

STOP USE AND ASK A DOCTOR IF

SPL UNCLASSIFIED SECTION

• Sore mouth symptoms do not improve in 7 days
• Swelling, rash or fever develops
• Irritation, pain, or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply only amount needed to the oral mucosa to prevent or relieve pain.
Children under 2 years of age: do not use.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

For professional use only in the practice of dentistry.
Store at 20°C - 25°C (68°F - 77°F). Do not permit to freeze.

HOW SUPPLIED

HOW SUPPLIED SECTION

Projel-20®, Benzocaine 20% is available in in 60 gram jars (NDC 0362-0125-05).

SPL UNCLASSIFIED SECTION

Manufactured by:
SEPTODONT, Inc.
416 S. Taylor Ave
Louisville, CO 80027
800-872-8305 |
www.septodontusa.com

Rev. 10/2018

Pina Colada Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pina Colada LabelPina Colada Label

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0362-01250362-0125-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML · Source PDF

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
238d0861-c7ae-4ba2-85a0-aff2b5dee4c7a28bedc0-bc10-4475-88aa-3a34bba6eb802020-05-14WarningsExact identifier
spl id: 238d0861-c7ae-4ba2-85a0-aff2b5dee4c7
spl set id: a28bedc0-bc10-4475-88aa-3a34bba6eb80

Reported adverse events (FAERS/openFDA)#

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