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ComfortCaine Topical Anesthetic

Medically reviewed on May 24, 2018

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g
Labeler: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
NDC Code: 68400-998

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.

Comfortcaine Mint

Active Ingredients (in each gram)

Benzocaine 200 mg

Purpose

Oral Anesthetic

Uses

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings

Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.

Do not use
  • for more than 7 days unless directed by a dentist or doctor.
  • If sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • if swelling, rash or fever develops, see your dentist or doctor promptly.

When using this product

Avoid contact with eyes. If contact occurs, flush with water.

Stop use and consult a health care practitioner

If the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray, or blue coloured skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.

Do not exceed recommended dosage.
  • If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.

Other information

Store at 59° to 86°F (15° to 30°C). Protect from freezing.

Inactive ingredients

Flavoring, polyethylene glycol base, sodium saccharin. May contain blue #1, red #3, red #33, red #40, yellow #6, yellow #10.

Questions or Comments?

1-800-333-3131 or 856-663-4700

www.keystoneind.com

Principle Display Panel

Bosworth ® ComfortCaine™

Topical Anesthetic

1 oz. (30g.)

BOSLAB-176 0516PR930

Bosworth ® Company

Manufactured for:

Harry J. Bosworth Company

A division of Keystone Industeries

480 South Democrat Road

Gibbstown, NJ 08027

800.333.3131

www.keystoneindustries.com

Made in USA

COMFORTCAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-998
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINT 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 3350 
SACCHARIN SODIUM 
SILICON DIOXIDE 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68400-998-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/199708/31/2020
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)

 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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