BABY SENSIGEL  - benzocaine gel 
Dr. Fresh, 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 Ingredient

Benzocaine 10%

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

SensiGel, Baby SensiGel and related trademarks, names, logos, and patents are the property of Dr. Fresh, Inc, and are registered and/or used in the U.S. and countries around the world.

(c)2011  Dr. Fresh, Inc.

Distributed by:

Dr. Fresh Inc.
Buena Park, CA 90620 USA

Canada  - Dr. Fresh, Inc.
Ontario, Canada L7C2T4

U.K. Grosvenor Consumer products Limited (Dr. Fresh, UK)
268 Bath Road Slough Berkshire SL 1 4DX  


Questions? Comments?
Toll Free: 1-866-373-7374
USA: +1-714-690-1573
UK AND IRL: +44(0) 1753 725365

comments@drfresh.com

visit us online at:
www.drfresh.com
www.drfesh.uk


BABY SENSIGEL            MADE IN USA

with added pain reliever

Benzocaine 10%

New!
Nighttime Formula

INSTANT TEETHING

PAIN

RELIEF Gel pen


Safe and Effective
Alcohol-Free
Great Tasting Favor For Baby

Oral Pain Reliever for Teething

Net Wt: 0.07oz (2.0g)

Product Label

SensiGel label


BABY SENSIGEL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-384
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYETHYLENE GLYCOLS 
SORBIC ACID 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:64893-384-022 g in 1 PACKAGENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/07/2011

Labeler - Dr. Fresh, Inc (033059119)

Revised: 10/2011 Dr. Fresh, Inc