BENZO JEL- benzocaine spray, metered

Benzo Jel by

Drug Labeling and Warnings

Benzo Jel by is a Otc medication manufactured, distributed, or labeled by Henry Schein Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

• For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
• For Professional Use Only.

Warnings

Flammable. Do not use near fire or flame. Avoid smoking during use.

​Do not use​ if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

​Stop use and ask a doctor if

• you experience any of the following symptoms:
• weakness
• confusion
• headache
• difficulty breathing
• pale, grey or blue colored skin as these may be signs of methemoglobinemai, a rare disorder, which may appear up to two hours after use.   

​Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.  Avoid spraying in eyes.   

Dosage

​A single metered spray dispenses 50 mg of Benzo-Jel Topical Anesthetic. Use only as directed by a dentist.

Other information

Store at room temperature.  Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Inactive ingredients

Ethyl Alcohol, Flavor, Polyethelyn Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane).

​Questions or comments?

1-800-472-4346

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZO JEL 
benzocaine spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0018
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	11.4 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white (CLEAR)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0018-35	57 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/01/2016

Labeler - Henry Schein Inc. (012430880)