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Sensicaine TM Extra Topical Anesthetic

Medically reviewed on Dec 17, 2017

Dosage form: gel
Ingredients: Benzocaine 200mg in 1g
Labeler: Safco Dental Supply Co.
NDC Code: 67239-0215

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 Raspberry Flavor

Active ingridients (in each gram)

Benzocaine 200 mg

Purpose

Oral Anesthetic

Use

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

Warnings

Allergy Alert: Do not useon 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; or 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 practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or
pale, grey or blue colored skin, as these 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.

Directions

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

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

Raspberry Flavor

1 oz. (29.6 mL)

For professional use only

SENSICAINE TM EXTRA  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0215
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 
D&C RED NO. 33 
FD&C RED NO. 40 
D&C GREEN NO. 5 
FD&C YELLOW NO. 5 
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67239-0215-129 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.

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Further information

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

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