TOPICAL ANESTHETIC  BUBBLE GUM- 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.

----------

SensiCaine Topical Anesthetic Gel Bubble Gum Flavor

INGREDIENTS

Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and D&C Red #28.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

WARNING

Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.

Store at controlled room temperature 59-86°F (15-30°C).

CAUTION

Federal law prohibits dispensing without a prescription.

Distributed by:
Safco Dental Supply Co.
Buffalo Grove, IL 60089
800-621-2178
www.safcodental.com

PRINCIPAL DISPLAY PANEL - Jar Label

SAFCO
SensiCaine

Topical Anesthetic Gel

Bubble Gum Flavor

Contains 20% Benzocaine

For Professional Use Only

1 oz. (34 g)

PRINCIPAL DISPLAY PANEL - Jar Label
TOPICAL ANESTHETIC   BUBBLE GUM
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0206
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 400 (UNII: B697894SGQ)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Water (UNII: 059QF0KO0R)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67239-0206-134 g in 1 JAR; Type 0: Not a Combination Product08/06/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35608/06/2012
Labeler - Safco Dental Supply Co. (020417380)
Registrant - Safco Dental Supply Co. (020417380)

Revised: 12/2017
Document Id: 7fa204a2-31c7-42bb-b68c-17166399864f
Set id: d642b80f-a04e-497c-8f9f-6747bc08f7ad
Version: 2
Effective Time: 20171217
 
Safco Dental Supply Co.