Active Ingredient
Benzocaine 20%
Alpha-caine Gel
FDA Label NDC 55346-2902
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dental Technologies, Inc. for the product Alpha-caine (NDC 55346-2902). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, methemoglobinemia warning, allergy alert:, sore throat warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Methemoglobinemia Warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.
Do Not Use
- for teething
- in children under 2 years of age
When Using This Product
avoid contact with eyes
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact Poison Control Center right away.
Directions
do not exceed recommended dosage.
- adults and children 2 years of age and older: apply to 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 dentist or doctor.
- children under 12 years of age: should be supervised in the use of the product.
- children under 2 years of age: do not use
Other Information
Store at 59° to 86° F (15° to 30° C)
Inactive Ingredients
Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10*
*contains one or more of these ingredients.
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
DENTAL TECHNOLOGIES, INC.
Lincolnwood, IL 60712
Made in U.S.A.
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
20% Benzocaine Oral Anesthetic
1oz. (30g)
Alpha-caine_mint_image.jpg (Alpha Caine Mint Image)
* Please review the disclaimer below.
