Skip to Content

← See all Sensicaine TM Extra Topical Anesthetic brands

Sensicaine TM Extra Topical Anesthetic

Dosage form: gel
Ingredients: Benzocaine 200mg in 1g
Labeler: Safco Dental Supply Co.
NDC Code: 67239-0211

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.

SensiCaineTM Extra Topical Anesthetic Gel Bubble Gum Flavor

Active ingridients (in each gram)

Benzocaine 200 mg

Purpose

Oral Anesthetic

Use

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

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.

Sore throat warning:If sore throat is severe,persists for more than 2 days,is accompanied or followed by fever, headache, rash, swelling, nausea,or vomiting, consult a doctor promptly.If sore mouth symptoms do not improve in 7 days, or if irritation,pain, or redness persist or worsen, see your dentist or doctor promptly.

Do not use
  • for teething
  • in children under 2 years of age

When using this product Avoid contact with eyes. If contact occurs, flush with water.

If pregnant or breast feeding, consult a doctor before use.

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions
  • adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain
  • children under 2 years of age: do not use

Other information
  • Store at 59 - 86ºF (15 - 30ºC).
  • Protect from freezing.

Inactive ingredients

flavoring, PEG 3350, PEG 400, sucralose. May contain D&C Red #33, FD&C Red #40, D&C Green #5, FD&C Yellow #5 as a color additive.

Questions or comments?

800-621-2178

www.safcodental.com

PRINCIPAL DISPLAY PANEL - Jar Label

SAFCO
SensiCaineTM Extra

Topical Anesthetic Gel

Contains 20% Benzocaine

Bubble Gum Flavor

For Professional Use Only

1 oz. (34 g)

SENSICAINE TM EXTRA  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0211
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 
Polyethylene Glycol 400 
Sucralose 
FD&C RED NO. 40 
D&C RED NO. 33 
D&C GREEN NO. 5 
FD&C YELLOW NO. 5 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67239-0211-129 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35604/30/2017
Labeler - Safco Dental Supply Co. (020417380)
Registrant - Safco Dental Supply Co. (020417380)

 
Safco Dental Supply Co.

← See all Sensicaine TM Extra Topical Anesthetic brands

Medically reviewed on Nov 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide