COMFORTCAINE- benzocaine gel

Comfortcaine by

Drug Labeling and Warnings

Comfortcaine by is a Otc medication manufactured, distributed, or labeled by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepack Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

COMFORTCAINE 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68400-994
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 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
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-994-01	30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1997	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/1997	09/30/2020

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