Your browser does not support JavaScript! COMFORTCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]
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COMFORTCAINE TOPICAL ANESTHETIC (benzocaine) gel
[Dental Technologies, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

For the temporary relief of occasional pain and minor irritation associated with:

  • canker sores
  • ulcers
  • minor dental procedures
  • needle punctures
  • minor injury of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
  • sore mouth and throat

Warnings

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

Stop use and ask a doctor if

  • Sore mouth symptoms do not improve in 7 days or if irritation, pain, or redness persists or worsens.
  • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, nausea, rash, swelling, or vomiting.

When using this product

  • Avoid contact with eyes

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.

Directions

Do not exceed recommended dosage. Adults and children 2 years of age or older

Apply to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 3 times daily or as directed by a dentist or doctor.

Children under 12 years of age Should be supervised in the use of the product.

Children under 2 years of age Consult a dentist or doctor

Other information:

Do not use if imprinted seal under cap is broken or missing.

Store at 59° to 86° F (15° to 30° C)

Inactive ingredients:

Flavoring, polyethylene glycol base, sodium saccharin.

Questions or Comments?

Call 1-800-323-4532 or 1/847-679-3400

M-F: 8:00AM to 5:00PM

Central Time

Bosworth® Company

7227 N. Hamlin Avenue

Skokie, IL 60076

800.323.4352

Principal Display Panel

Bosworth® ComfortCaine™

Topical Anesthetic

NDC 55346-1404-1

Ref 16603

1 oz.(30g.)

Cherry

0510PR725

image of carton

COMFORTCAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55346-1404
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 400 
Polyethylene Glycol 3350 
SACCHARIN SODIUM 
SILICON DIOXIDE 
FD&C RED NO. 3 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55346-1404-130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/1997
Labeler - Dental Technologies, Inc. (148312838)

Revised: 11/2012
 
Dental Technologies, Inc.

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