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Benzo-Jel by Henry Schein Inc.

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g
Labeler: Henry Schein Inc.
NDC Code: 0404-0033

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 (in each gram)

Benzocaine 200 mg

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
  • ​Allergy Alert:​ Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
  • ​Do Not Use​ for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
  • ​When using this product​ avoid contact with eyes. If contat occurs, flush with water.
  • ​Stop use and consult a health care practitioner​ if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rae disorder, which may appear up to 2 hours after use.
  • ​Do not exceed recommended dosage.​ If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • ​If pregnant or breast feeding, ​ask a health professional before use. 

​Keep Out of Reach of Children.

Keep Out of Reach of Children.

​Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.

​Other Information

Store at 59º -86°F (15 - 30°C).

Prorect from freezing.

​Inactive ingredients

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

Questions or comments?

1-800-472-4346

BENZO-JEL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0033
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
WATER 
FD&C BLUE NO. 1 
D&C GREEN NO. 5 
FD&C RED NO. 3 
D&C RED NO. 28 
FD&C YELLOW NO. 5 
FD&C RED NO. 40 
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0404-0033-3030 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2016
Labeler - Henry Schein Inc. (012430880)

 
Henry Schein Inc.

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Medically reviewed on Jul 25, 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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