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Hurricaine topical anesthetic - Medication Information

Product NDC Code 0283-0871
Drug Name

Hurricaine topical anesthetic

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Increased Histamine Release [PE],
Standardized Chemical Allergen [EPC]
Active Ingredients
Benzocaine 200 mg/g
Route DENTAL, ORAL, PERIODONTAL
Dosage Form GEL
RxCUI drug identifier 238910,
996288
Application Number part356
Labeler Name Beutlich Pharmaceuticals, LLC
Packages
Package NDC Code Description
0283-0871-12 12 box in 1 cello pack (0283-0871-12) / 1 tube in 1 box (0283-0871-75) / 5.25 g in 1 tube (0283-0871-01)
0283-0871-31 1 bottle, plastic in 1 box (0283-0871-31) / 28.4 g in 1 bottle, plastic
0283-0871-59 60 cup, unit-dose in 1 box (0283-0871-59) / .5 g in 1 cup, unit-dose (0283-0871-45)
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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 Directions: Do not exceed recommended dosage. adults and children 2 years of age and older: apply to the affected area. 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: do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients flavor, polyethylene glycol, sodium saccharin

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: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures 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.
HurriCaine Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM BENZOCAINE BENZOCAINE amber

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 WHAT YOUR DENTIST USES NDC 0283-0871-75 HURRICAINE® Topical Anesthetic GEL 20% Benzocaine Oral Anesthetic ORIGINAL WILD CHERRY Manufactured for: Beutlich® Pharmaceuticals, LLC Bunnell, FL Made in the USA 1 Tube - NET WT. 0.18 oz. (5.25 g) tube packaging image

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

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? 1-800-238-8542 M-F: 8:00 a.m. - 4:30 p.m. ET

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Do not use Do not use: if the tube has been punctured or previously opened for teething in children under 2 years of age

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

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20°-25° C (68°-77° F)

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 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 local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, 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