Comfortcaine Cherry

Drug Labeling and Warnings

Drug Details [pdf]

COMFORTCAINE TOPICAL ANESTHETIC- benzocaine gel 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak 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 Cherry

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68400-999
Route of Administration	DENTAL

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	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-999-01	30 g in 1 JAR; Type 0: Not a Combination Product	01/01/1997	10/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/1997	10/31/2019

Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)

Revised: 5/2018

Document Id: 6cf42857-6426-a60b-e053-2991aa0aa2f1

34390-5

Set id: 5faf4114-87de-255f-e053-2a91aa0a755d

Version: 2

Effective Time: 20180524

 

Mycone Dental Supply Co., Inc DBA Key