TOPICAL ANESTHETIC MINT- 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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SensiCaine Topical Anesthetic Gel Mint 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 Green #5.

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

Mint Flavor

Contains 20% Benzocaine

For Professional Use Only

1 oz. (34 g)

PRINCIPAL DISPLAY PANEL - 29.6 g Jar Label

TOPICAL ANESTHETIC MINT
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67239-0203
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Water (UNII: 059QF0KO0R)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67239-0203-1	34 g in 1 JAR; Type 0: Not a Combination Product	08/06/2012	10/15/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	08/06/2012	10/15/2018

Labeler - Safco Dental Supply Co. (020417380)

Registrant - Safco Dental Supply Co. (020417380)

Revised: 12/2018

Document Id: 51064334-5bf4-4266-86e0-88cee8ed099a

Set id: bd6e83a7-6112-4c53-b194-a74ee135deb5

Version: 3

Effective Time: 20181218

Safco Dental Supply Co.