SENSICAINE TM EXTRA TOPICAL ANESTHETIC- benzocaine gel 
Safco Dental Supply Co.

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.

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SensiCaineTM Extra Topical Anesthetic Gel Cherry 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:

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

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

Other information

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

Cherry Flavor

For Professional Use Only

1 oz. (34 g)

PRINCIPAL DISPLAY PANEL - 29.6 g Jar Label
PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label 2
SENSICAINE TM EXTRA  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0212
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Sucralose (UNII: 96K6UQ3ZD4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67239-0212-129 g in 1 JAR; Type 0: Not a Combination Product04/30/2017
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)

Revised: 11/2018
Document Id: bb75f6d8-665c-487b-b940-b12195156a06
Set id: 281fe03e-badb-4620-8918-ed56a6149317
Version: 3
Effective Time: 20181111
 
Safco Dental Supply Co.