COMFORTCAINE- benzocaine gel 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepack Products 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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Comfortcaine - Strawberry

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 pracitioner

if the following symptoms appear.

  • weakness
  • confusion
  • headache
  • difficulty breathing
  • pale
  • grey or blue colored skin, as this 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 teh oral mucosa to prevent or relieve pain.

Other information

Store at 59º - 86ºF (15-30ºC). 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

Principal Display Panel

Bosworth® ComfortCaine™

Topical Anesthetic

1 oz. (30g.)

BOSLAB-176 0516PR930

bosworth_benzo

COMFORTCAINE 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-994
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-994-0130 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/199709/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/199709/30/2020
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepack Products Inc. (014769301)

Revised: 5/2018
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepack Products Inc.