Your browser does not support JavaScript! ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]
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ALPHA-CAINE TOPICAL ANESTHETIC (benzocaine) gel
[Dental Technologies, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

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

  • Sore mouth and throat
  • Ulcers
  • Minor dental procedures
  • Needle punctures
  • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

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:

  • pale, gray or blue-colored skin, lips and nail beds
  • shortness of breath
  • fatigue
  • confusion
  • headache
  • light-headedness
  • rapid heart rate

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

  • do not exceed recommended dosage.

  • adults and children 2 years of age and older: Apply to the affected area. Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.

  • children under 12 years of age: Should be supervised in the use of the product.

  • children under 2 years of age: Consult a dentist or doctor.

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
 
Dental Technologies, Inc.

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