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Projel-20 by Septodont, Inc.

Dosage form: gel
Ingredients: BENZOCAINE 20g in 100g
Labeler: Septodont, Inc.
NDC Code: 0362-0125

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 Pina Colada

Active ingredient:

benzocaine 20%

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.

Pina Colada Projel

PROJEL-20 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0362-0125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
POLYETHYLENE GLYCOL 3350 
POLYETHYLENE GLYCOL 300 
Packaging
#Item CodePackage Description
1NDC:0362-0125-0560 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(0362-0125), label(0362-0125)

Revised: 11/2015
 
Septodont, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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