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Projel-20 by Septodont, Inc.

Dosage form: gel
Ingredients: BENZOCAINE 201 in 100g
Labeler: Septodont, Inc.
NDC Code: 0362-0122

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.

Projel-20 Cherry 

Active ingredient:

Benzocaine

Inactive ingredients:

flavor, polyethylene glycol, sodium saccharin

Purpose:

Oral Anesthetic

Keep Out of Reach of Children

Indications and Usage:

For temporary pain relief of oral mucosa due to minor irritation or injury of the moth and gums or of pain associated with canker sors, dentures or orthodontic appliances. For topical application to oral mucosa only.

Dosage and Administration

For professional use only in the practice of dentistry

Warnings:

PATIENT SHOULD NOT INGET OR SWALLOW. AVOID CONTACT WITH EYES.

Localized allergic reactions may occur after prolonged or repeated use. Do not use on patients with history of allergy due to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Discontinue use if irritation-inflammation or fever and infection develops.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Cherry Projel

PROJEL-20 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0362-0122
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20   in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
POLYETHYLENE GLYCOL 300 
POLYETHYLENE GLYCOL 3350 
Packaging
#Item CodePackage Description
1NDC:0362-0122-0560 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/15/1989
Labeler - Septodont, Inc. (627058738)
Establishment
NameAddressID/FEIOperations
Septodont Inc.012925513manufacture(0362-0122), label(0362-0122)

 
Septodont, Inc.

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Medically reviewed on Nov 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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