Label: COMFORTCAINE TOPICAL ANESTHETIC- benzocaine gel
- NDC Code(s): 55346-1404-1
- Packager: Dental Technologies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated November 15, 2012
If you are a consumer or patient please visit this version.
- Active Ingredient
For the temporary relief of occasional pain and minor irritation associated with:
- canker sores
- minor dental procedures
- needle punctures
- minor injury of the mouth and gums
- minor irritation of the mouth and gums caused by dentures or orthodontic appliances
- sore mouth and throat
Do not use if you have a history of allergy to any "caine" anesthetics, such as benzocaine, butacaine, procaine, or tetracaine.Close
- 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
- 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.Close
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 doctorClose
- Other information:
Do not use if imprinted seal under cap is broken or missing.
Store at 59° to 86° F (15° to 30° C)Close
- Inactive ingredients:
Flavoring, polyethylene glycol base, sodium saccharin.Close
- Questions or Comments?
Call 1-800-323-4532 or 1/847-679-3400
M-F: 8:00AM to 5:00PM
- SPL UNCLASSIFIED SECTION
7227 N. Hamlin Avenue
Skokie, IL 60076
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
COMFORTCAINE TOPICAL ANESTHETIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55346-1404 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 (Cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55346-1404-1 30 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/01/1997 Labeler - Dental Technologies, Inc. (148312838)