BENZO-JEL- benzocaine gel 
Henry Schein 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.

----------

Active Ingredients 

Benzocaine 200 mg (in each g)

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

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 the 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)

Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use

When using this product Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.

Keep Out of Reach of Children.

​Directions

​Other Information

Store at 59º-86°F (15-30°C). Protect from freezing.

​Inactive ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions or comments?

1-800-472-4346

HenrySchein_Topical_Wrap.jpg

BENZO-JEL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0039
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0039-3030 g in 1 JAR; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2016
Labeler - Henry Schein Inc. (012430880)

Revised: 1/2022
Document Id: d58f89da-8f7d-3cd8-e053-2995a90aecaf
Set id: a9dc2245-c029-4453-bfc5-8fb899873c34
Version: 3
Effective Time: 20220114
 
Henry Schein Inc.