Comfortcaine

Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepack Products Inc.
Effective date
2018-05-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:57:21

Label at a glance#

ProductComfortcaine
Active ingredientBENZOCAINE
Label structure15 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 200 mg

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

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

Stop use and consult a health care pracitioner

OTC - STOP USE SECTION

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.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

Store at 59º - 86ºF (15-30ºC). Protect from freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-333-3131 or 856-663-4700 www.keystoneind.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bosworth® ComfortCaine™

Topical Anesthetic

1 oz. (30g.)

BOSLAB-176 0516PR930

bosworth_benzobosworth_benzo

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68400-99468400-994-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6cf42857-63fc-a60b-e053-2991aa0aa2f1603ef657-b34e-633f-e053-2a91aa0a847f2018-05-24WarningsExact identifier
spl id: 6cf42857-63fc-a60b-e053-2991aa0aa2f1
spl set id: 603ef657-b34e-633f-e053-2a91aa0a847f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.