Comfortcaine description, usages, side effects, indications, overdosage, supplying and lots more!

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Comfortcaine

Dental Technologies, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Comfortcaine Uses

For the temporary relief of occasional pain and minor irritation associated with:

  • canker sores
  • ulcers
  • minor dental procedures
  • needle punctures
  • minor injury of the mouth and gums
  • minor irritation of mouth and gums caused by dentures or orthodontic appliances
  • sore mouth and throat

Warnings

Do not use if you have a history of allergy to any "caine" anesthetics, such as benzocaine, butacaine, procaine, or tetracaine.

Stop use and ask a doctor if

  • Sore mouth symptoms do not improve in 7 days or if irritation, pain, or redness persists or worsens.
  • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, nausea, rash, swelling, or vomiting.

When using this product

  • Avoid contact with eyes

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage. Adults and children 2 years of age or older

Apply to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 3 times daily or as directed by a dentist or doctor.

Children under 12 years of age Should be supervised in the use of the product.

Children under 2 years of age Consult a dentist or doctor

Other information:

Do not use if imprinted seal under cap is broken or missing.

Store at 59° to 86° F (15° to 30° C)

Inactive ingredients:

Flavoring, polyethylene glycol base, sodium saccharin.

Questions or Comments?

Call 1-800-323-4532 or 1/847-679-3400

M-F: 8:00AM to 5:00PM

Central Time

Bosworth® Company

7227 N. Hamlin Avenue

Skokie, IL 60076

800.323.4352

Principal Display Panel

Bosworth® ComfortCaine™

Topical Anesthetic

NDC 55346-1401-1

Ref 16602

1 oz.(30g.)

Pina Colada

0111PR724

Comfortcaine

Comfortcaine

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55346-1401
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 200 mg

Inactive Ingredients

Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
polyethylene glycol 400
saccharin sodium
SILICON DIOXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55346-1401-1 30 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 1997-01-01


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Be sure to consult your doctor before taking any medication!
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