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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Drug Facts

Active Ingredient:

Benzocaine 20%

Inactive Ingredients:

PEG-8, PEG-75, Sodium Saccharin, Flavor, FD&C Red # 3.

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

BUBBLE GUM

1 oz. (30g)

REF 029.0401.002

image of carton

ALPHA-CAINE TOPICAL ANESTHETIC
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:55346-2904
Route of Administration	TOPICAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
Polyethylene Glycol 400
Polyethylene Glycol 3350
SACCHARIN SODIUM
FD&C RED NO. 3

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM (Bubble Gum)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55346-2904-1	30 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	12/31/1999

Labeler - Dental Technologies, Inc. (148312838)

Registrant - Dental Technologies, Inc. (148312838)

Name	Address	ID/FEI	Business Operations
Establishment
Dental Technologies, Inc.		148312838	manufacture(55346-2904), pack(55346-2904), label(55346-2904)

Revised: 8/2012

Document Id: 824270ab-5b00-44fe-80d0-2507b5ee7f66

Set id: e6a312e5-17ac-46f0-8723-4e40eeecd69f

Version: 3

Effective Time: 20120813

Dental Technologies, Inc.