SENSIGEL- benzocaine gel
Dr. Fresh, LLC

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.

----------

MAXIMUM STRENGTH SENSIGEL

Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral Pain Reliever

Use

for the temporary relief of pain due to toothaches.

Warnings

For external use only.

Allergy Alert: do not use the product if you havd a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Do not use

for more than 7 days unless recommended by a dentist or doctor.

Stop use and ask a doctor if

swelling, rash or fever develops - irritation, pain or redness persists or worsens

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash hands - remove pen cap - twist the bottom several times until the brush tip is covered with the gel.

Adults and children 6 years of age and older: Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age - Should be supervised in the use of this product. Children under 6 years of age: Ask a dentist or doctor.

Other Information

Do not use if pen or package has been opened. This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can b consulted. Do not use continuously. This formula will stay in place for an extended duration for relief.

Inactive Ingredients

Flavor, Glycerin, Polyethylene Glycol, Polyvinyl Pyrrolidone, Sorbic Acid, Sucralose, Red No. 40

Package Labeling:

SENSIGEL
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-385
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBIC ACID (UNII: X045WJ989B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-385-02	2 g in 1 PACKAGE; Type 0: Not a Combination Product	09/26/2011	08/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	09/26/2011	08/31/2019

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: bc0a8b5a-c593-492c-bbf0-847ef9ba1946

Set id: 34c03e21-96f4-42b2-973d-74368243176f

Version: 6

Effective Time: 20210922

Dr. Fresh, LLC