PROJEL-20- benzocaine gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Available from:

Septodont, Inc.

Administration route:

Topical

Prescription type:

OTC DRUG

Therapeutic indications:

Oral Anesthetic intended for adults and children 2 years of age and older. 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. • 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 • Sore mouth symptoms do not improve in 7 days • Swelling, rash or fever develops • Irritation, pain, or redness persists or worsens.

Product summary:

Projel-20® , Benzocaine 20% is available in in 60 gram jars (NDC 0362-0122-05).

Authorization status:

OTC monograph final

Summary of Product characteristics

PROJEL-20- BENZOCAINE GEL
SEPTODONT, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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PROJEL-20 CHERRY
ACTIVE INGREDIENT:
Benzocaine 20%
INACTIVE INGREDIENTS:
Flavor, polyethylene glycol, sodium saccharin
PURPOS E:
Oral Anesthetic intended for adults and children 2 years of age and
older.
US E:
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 inf