HURRICAINE

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

BENZOCAINE

Disponível em:

A. LEVY DENTAL CO. LTD, ISRAEL

Código ATC:

D04AB04

Forma farmacêutica:

GEL

Composição:

BENZOCAINE 20 %W/W

Via de administração:

LOCAL ORAL

Tipo de prescrição:

Not required

Fabricado por:

BEUTLICH PHARMACEUTICALS LLC, USA

Grupo terapêutico:

BENZOCAINE

Área terapêutica:

BENZOCAINE

Indicações terapêuticas:

Hurricaine is designed for any dental procedure in which topical anesthesia is desired. Hurricaine is also used for temporary relief of occasional minor irritation and pain associated with: canker sores, sore mouth and throat , minor injury of the mouth and gums caused by dentures or orthodentic appliances.

Data de autorização:

2014-11-30

Folheto informativo - Bula

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed without a doctor’s prescription
HURRICAINE
GEL FOR ORAL USE
1) NAME OF THE MEDICINE, ITS FORM AND STRENGTH:
NAME OF THE MEDICINE: Hurricaine
FORM: Gel for oral use
THE ACTIVE INGREDIENT AND ITS CONCENTRATION PER DOSAGE UNIT:
Benzocaine 20% w/w
For a list of inactive and allergenic ingredients in the medicine -
see section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
The medicine is intended for both men and women. Use the medicine in
the correct
manner. Consult the pharmacist if you need further information.
Refer to the dentist or doctor if the symptoms worsen or do not
improve after 7
days.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine provides topical oral anesthesia, when a medical
procedure has to be
performed in the mouth.
The medicine provides temporary relief in cases of pains or minor
irritation in the
mouth, associated with cases of:
∙ Mouth ulcers
∙ Sore mouth and throat
∙ Mild damage in the oral cavity and on the gums caused by use of
dentures or other
oral devices.
THERAPEUTIC GROUP: local anesthetic.
2) BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE:
- if you are sensitive (allergic) to the active ingredient or to any
of the inactive
ingredients contained in the medicine. The active ingredient is
mentioned in section
1 and the inactive ingredients are listed in section 6. An allergic
reaction can be
manifested by appearance of a rash, itching, swelling or burning.
- if you or your relatives suffer from methemoglobinemia.
- in children below the age of 12.
SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE:
- Refer to the dentist or doctor if the symptoms worsen or do not
improve within 7
days.
- If you are sensitive to any food or medicine, inform the dentist or
doctor before using
the medicine.
- Do not use the med

Características técnicas

Page 1 of 2
PHYSICIANS’ PRESCRIBING INFORMATION
HURRICAINE
®
Topical Anesthetic Gel for Oral Use
20% Benzocaine Oral Anesthetic
1. NAME OF THE MEDICINAL PRODUCT:
HURRICAINE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Benzocaine 20% w/w
For full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM:
Gel for oral use (dental gel)
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
HURRICAINE is designated for any dental procedure in which topical
anesthesia is
desired. HURRICAINE is also used for temporary relief of occasional
minor irritation and pain associated with: canker
sores, sore mouth and throat, minor injury of the mouth and gums
caused by dentures or orthodentic appliances.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
Adults and children aged 12 years and over.
Directions:

Spit out, swallow or vacuum excess saliva from mouth

With a clean finger or swab apply an amount of
gel the size of a green pea into the tooth cavity or to the affected
area, to form a thin film

Allow to remain in place at
least 1 minute and then spit out

Do not re-use or re-dip in the gel the finger or swab once placed in
mouth. This will
prevent cross-contamination of the gel

Use up to 4 times daily. Do not exceed recommended dosage

Do not use
continuously. If toothache persists, consult your dentist.
Not for use in children below the age of 12 years.
HURRICAINE is designed for rapid onset (10-30 seconds). Anesthesia
usually lasts 8-10 minutes. Benzocaine has been
shown to be a safe, effective anesthetic with little or no systemic
absorption.
4.3 CONTRAINDICATIONS:
Known sensitivity to benzocaine or any of the other ingredients.
Not to be used in those individuals suspected of lacking the normal
ability to convert methaemoglobin to haemoglobin, see
Section 4.4 Special warnings and precautions for use and Section 4.8
Undesirable effects.
Not for use in children below the age of 12 years.
HURRICAINE is not for injection. Avoid contact with eyes.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Do not use i