PROJEL-20- benzocaine gel

Projel-20 by

Drug Labeling and Warnings

Projel-20 by is a Otc medication manufactured, distributed, or labeled by Septodont, Inc., Septodont Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Benzocaine 20%

Inactive Ingredients:

Flavor, polyethylene glycol, sodium saccharin.

Purpose:

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

Use:

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 

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

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

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

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

KEEP OUT OF REACH OF CHILDREN

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:

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

OTHER INFORMATION

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

Projel-20®, Benzocaine 20% is available in in 60 gram jars (NDC: 0362-0124-05).

SPL UNCLASSIFIED SECTION

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

Rev. 10/2018

Bubblegum Projel Label

INGREDIENTS AND APPEARANCE

PROJEL-20 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0362-0124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0362-0124-05	60 g in 1 JAR; Type 0: Not a Combination Product	12/15/1989

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/15/1989

Labeler - Septodont, Inc. (627058738)

Establishment
Name	Address	ID/FEI	Business Operations
Septodont Inc.		012925513	manufacture(0362-0124) , label(0362-0124)