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%

Purpose

Oral Anesthetic

Uses

For the temporary relief of occasional minor irritation and pain, associated with:

Warnings

For external use only

Allergy alert: Do not use if you have a history of allergy to any "caine" anesthetics, such as benzocaine, butacaine, procaine, or tetracaine.

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

When using this product

avoid contact with eyes

Stop use and ask a doctor if

you experience any of the following symptoms, as these may be a sign of methemoglobinemia, a rare disorder which can appear up to 2 hours after use:

If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

´╗┐Directions

Other information

Store at 59° to 86º F (15º to 30º C)

Inactive ingredients

Blue 1, flavor, PEG-8, PEG-75, sodium saccharin, Yellow 10

´╗┐Questions or comments?

1-800-835-0885 or 1-847-677-5500

M-F 8:00 a.m. - 4:30 p.m. CST.

Visit www.dentaltech.com

Principal Display Panel

DENTAL TECHNOLOGIES

www.dentaltech.com

ALPHA-CAINE®

TOPICAL ANESTHETIC GEL

20% Benzocaine Oral Anesthetic

MINT

1 oz. (30g)

REF 029.0201.002

image description

DENTAL TECHNOLOGIES, INC.

Lincolnwood, IL 60712

Made in U.S.A.

DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

ALPHA-CAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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(55346-2902), pack(55346-2902), label(55346-2902)

Revised: 1/2014
Document Id: d3dd51d5-7aef-4679-9e97-8daaf218ed5e
Set id: ae628766-25b7-4b4f-abb8-a43faf2f44b9
Version: 5
Effective Time: 20140121
 
Dental Technologies, Inc.