COMFORTCAINE TOPICAL ANESTHETIC- benzocaine gel 
Dental Technologies, 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.

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Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

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

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

When using this product

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® ComfortCaineâ„¢

Topical Anesthetic

NDC 55346-1404-1

Ref 16603

1 oz.(30g.)

Cherry

0510PR725

image of carton

COMFORTCAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55346-1404
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine 200 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (Cherry) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55346-1404-1 30 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/01/1997
Labeler - Dental Technologies, Inc. (148312838)

Revised: 11/2012
Document Id: 24d87084-a853-4fe3-88ff-a1777276bd46
Set id: 7c7b9762-80c7-4525-a296-fc135ceb2ee3
Version: 3
Effective Time: 20121115
 
Dental Technologies, Inc.