SENSIGEL- benzocaine gel

SensiGel by

Drug Labeling and Warnings

SensiGel by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fcats

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:

INGREDIENTS AND APPEARANCE

SENSIGEL 
benzocaine gel

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

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

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

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

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

Labeler - Dr. Fresh LLC (117376803)