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.

----------

Active Ingredient:

Benzocaine 20%

Inactive Ingredients:

PEG-8, PEG-75, Sodium Saccharin, Flavor, DandC Red #33.

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

Cherry

1 oz. (30g)

REF 029.0301.002

image of carton

Enter section text here

Enter section text here


ALPHA-CAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-2903
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 Red No. 33 
Saccharin Sodium Dihydrate 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55346-2903-130 g in 1 BOTTLE, PLASTICNone

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/FEIOperations
Dental Technologies, Inc.148312838manufacture, pack, label

Revised: 08/2012 Dental Technologies, Inc.