FDA Label for Hurricaine Topical Anesthetic
View Indications, Usage & Precautions
Hurricaine Topical Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Beutlich Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingedient
Benzocaine 20%
Purpose
Oral Anesthetic
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
Warnings
Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butaine, benzocaine or other "caine" anesthetics.
Stop Use And Ask Doctor If
- sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting
- sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens
- if the product film is punctured or damaged
for teething
in children under 2 years of age
DO NOT USE:
When Using This Product
- avoid contact with eyes
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.
Adverse Reactions:
Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.
Directions
- do not exceed recommend 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: consult a dentist or doctor
Other Information
- do not use if imprinted seal under cap is broken or missing
- store at 20-25 °C (68-77 °F)
Inactive Ingredient
flavor, polyethylene glycol, sodium saccharin
Questions Or Comments?
1-800-238-8542
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HurriCaine Unit Dose Gel Mint 0.5g with Swab: 0283-0998-45
60ct HurriCaine Unit Dose Gel Mint 0.5g with Swab: 0283-0998-59
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