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| Product NDC Code | 55346-2902 | ||||
|---|---|---|---|---|---|
| Drug Name | Alpha-caine topical anesthetic |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | DENTAL, PERIODONTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 238910, 1297832 |
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| Application Number | M022 | ||||
| Labeler Name | Dental Technologies, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzocaine 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Alpha-Caine Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM FD&C BLUE NO. 1 D&C YELLOW NO. 10 BENZOCAINE BENZOCAINE Mint
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Allergy alert: Do not use if you have a history of allergy to any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.
Do not use for teething in children under 2 years of age
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at 59° to 86º F (15º to 30º C)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API