ALPHA-CAINE TOPICAL ANESTHETIC- benzocaine gel 
Dental Technologies, Inc.

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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Active Ingredient:

Benzocaine 20%

Inactive Ingredients:

PEG-8, PEG-75, Sodium Saccharin, Flavor, FDandC Blue #1, DandC Yellow #10.

Indications for use:

For oral Mucosal.


Warning:

Keep out of reach of children.

Do not use

if imprinted seal under cap is missing or broken.

For professional use only.

Principal Display Panel

Dental Technologies

www.dentaltech.com  

ALPHA-CAINE™

Topical Anesthetic Gel

Mint

1 oz. (30g)

REF 029.0201.002

image of carton

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ALPHA-CAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-2902
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 
Polyethylene Glycol 3350 
D&C YELLOW No. 10 
Saccharin Sodium Dihydrate 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55346-2902-130 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/31/1999
Labeler - Dental Technologies, Inc. (148312838)
Registrant - Dental Technologies, Inc. (148312838)
Establishment
NameAddressID/FEIBusiness Operations
Dental Technologies, Inc.148312838manufacture, pack, label

Revised: 06/2012
Document Id: 8cc4242f-4177-44ac-aeae-04a82610c89c
Set id: ae628766-25b7-4b4f-abb8-a43faf2f44b9
Version: 1
Effective Time: 20120601
 
Dental Technologies, Inc.